Roche Diagnostics GmbH
Indianapolis, IN, US
ROCHE DIAGNOSTICS GMBH appears in FDA device records in Indianapolis, IN. FDA records list 465 510(k) clearances between and , 444 PMA records and 3 registered establishments. As of , FDA records show 391 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Roche Diagnostics GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Roche Diagnostics Operations, Inc.registration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 465FDA records hold 465 510(k) clearances for Roche Diagnostics GmbH between 1998 and 2026. The busiest year on record is 2003, with 38. The most recent is 2026, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 3 |
| 1999 | 22 |
| 2000 | 36 |
| 2001 | 37 |
| 2002 | 21 |
| 2003 | 38 |
| 2004 | 25 |
| 2005 | 30 |
| 2006 | 26 |
| 2007 | 19 |
| 2008 | 17 |
| 2009 | 16 |
| 2010 | 34 |
| 2011 | 19 |
| 2012 | 13 |
| 2013 | 14 |
| 2014 | 16 |
| 2015 | 6 |
| 2016 | 7 |
| 2017 | 11 |
| 2018 | 7 |
| 2019 | 4 |
| 2020 | 3 |
| 2021 | 4 |
| 2022 | 10 |
| 2023 | 7 |
| 2024 | 4 |
| 2025 | 7 |
| 2026 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | PZI | Substantially Equivalent | |
| K252431 | Elecsys Calcitonin | JKR | Substantially Equivalent | |
| K252280 | Elecsys Anti-SARS-CoV-2 S | QVP | Substantially Equivalent | |
| K260049 | Elecsys Anti-HBc IgM | SEI | Substantially Equivalent | |
| K260048 | Elecsys Anti-HAV IgM | LOL | Substantially Equivalent | |
| K260046 | Elecsys Anti-HBc II | SEI | Substantially Equivalent | |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | NQD | Substantially Equivalent | |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | CEM | Substantially Equivalent | |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | CFR | Substantially Equivalent | |
| K253839 | Elecsys Anti-SARS-CoV-2 | QVP | Substantially Equivalent | |
| K253188 | CoaguChek XS Plus System | GJS | Substantially Equivalent | |
| K252163 | Elecsys Phospho-Tau (181P) Plasma | SET | Substantially Equivalent | |
| K242505 | Elecsys Cortisol III | JFT | Substantially Equivalent | |
| K250768 | Elecsys Anti-SARS-CoV-2 | QVP | Substantially Equivalent | |
| K241453 | Elecsys sFlt-1 and Elecsys PlGF | QWH | Substantially Equivalent | |
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | DFC | Substantially Equivalent | |
| K233060 | Elecsys Folate III | CGN | Substantially Equivalent | |
| K220272 | cobas pulse blood glucose monitoring system | PZI | Substantially Equivalent | |
| K231927 | Elecsys PTH , Elecsys PTH STAT | CEW | Substantially Equivalent | |
| K233454 | ONLINE TDM Methotrexate | LAO | Substantially Equivalent | |
| K221890 | Elecsys Tg II | MSW | Substantially Equivalent | |
| K222610 | Elecsys Anti-Tg | JZO | Substantially Equivalent | |
| K223637 | Elecsys proBNP II, Elecsys proBNP II STAT | NBC | Substantially Equivalent | |
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | QSE | Substantially Equivalent | |
| K220456 | Elecsys FT4 IV | CEC | Substantially Equivalent | |
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | MOJ | Substantially Equivalent | |
| K221693 | Elecsys Anti-HCV II (08837031190) | MZO | Substantially Equivalent | |
| K221765 | ONLINE DAT Benzodiazepines II | JXM | Substantially Equivalent | |
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | QSE | Substantially Equivalent | |
| K220924 | Elecsys HSV-2 IgG (08948887160) | MYF | Substantially Equivalent | |
| K220923 | Elecsys HSV-1 IgG (08948844160) | MXJ | Substantially Equivalent | |
| K220911 | Elecsys CMV IgG | LFZ | Substantially Equivalent | |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH | CFR | Substantially Equivalent | |
| K220176 | Elecsys AFP | LOJ | Substantially Equivalent | |
| K203757 | Elecsys AMH | PQO | Substantially Equivalent | |
| K211685 | Elecsys Testosterone II | CDZ | Substantially Equivalent | |
| K210546 | Elecsys proBNP II, Elecsys proBNP II STAT | NBC | Substantially Equivalent | |
| K201441 | Elecsys Troponin T Gen 5 | MMI | Substantially Equivalent | |
| K210901 | Elecsys Vitamin D total III | MRG | Substantially Equivalent | |
| K203227 | Elecsys HCG STAT | DHA | Substantially Equivalent | |
| K211302 | Elecsys Syphilis | LIP | Substantially Equivalent | |
| K200811 | cobas u 701 microscopy analyzer | LKM | Substantially Equivalent | |
| K192815 | Elecsys BRAHMS PCT | PRI | Substantially Equivalent | |
| K193313 | Elecsys Anti-TSHR | JZO | Substantially Equivalent | |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | CFR | Substantially Equivalent | |
| K190428 | Elecsys Anti-HAV II | LOL | Substantially Equivalent | |
| K183432 | cobas u 601 urinalysis test system | JIL | Substantially Equivalent | |
| K190773 | Elecsys TSH | JLW | Substantially Equivalent | |
| K173857 | Elecsys Tacrolimus | MLM | Substantially Equivalent | |
| K181233 | Elecsys FT4 III | CEC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610126 | 3002806559 | ROCHE DIAGNOSTICS GMBH | SANDHOFER STRASSE 116, MANNHEIM Baden-Wurttemberg D-68305 DE | 2026 | and 262 more, listed in full below |
| 9610529 | 3002806560 | ROCHE DIAGNOSTICS GMBH | NONNENWALD 2, PENZBERG Bavaria D-82377 DE | 2026 | and 99 more, listed in full below |
| 1823260 | 1823260 | ROCHE DIAGNOSTICS OPERATIONS INC | 9115 Hague Rd, Indianapolis, IN 46250 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CJXAcid Phosphatase, Disodium Phenylphosphate
- CGNAcid, Folic, Radioimmunoassay
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- CBTArterial Blood Sampling Kit
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DBFFerritin, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
- DAHGamma Globulin, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- CHNImmunochemical, Ceruloplasmin
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DELLipoprotein X, Antigen, Antiserum, Control
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- DDRMyoglobin, Antigen, Antiserum, Control
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- CDDRadioassay, Vitamin B12
- CKGRadioimmunoassay, Acth
- CIZRadioimmunoassay, Androstenedione
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- DCNSystem, Test, C-Reactive Protein
- CHWTitrimetric With Edta And Indicator, Calcium
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
Showing 25 of 391| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1476-2026 | cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel. | Class II | Open, Classified | |
| Z-1009-2026 | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody. | Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment. | Class II | Open, Classified | |
| Z-0489-2025 | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias) | Class II | Open, Classified | |
| Z-3187-2024 | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190 | Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis. | Class II | Open, Classified | |
| Z-0352-2024 | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503) | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. | Class II | Open, Classified | |
| Z-0952-2023 | cobas infinity central lab, Material Number 07154003001 | A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions. | Class II | Open, Classified | |
| Z-1515-2022 | cobas e801 Immunoassay Analyzer | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. | Class II | Open, Classified | |
| Z-0266-2022 | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity. | A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L. | Class II | Terminated | |
| Z-2444-2021 | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 | Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument. | Class II | Terminated | |
| Z-1675-2021 | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems. | Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer. | Class II | Open, Classified | |
| Z-1596-2021 | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed. | Class II | Open, Classified | |
| Z-1595-2021 | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction. | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed. | Class II | Open, Classified | |
| Z-1098-2021 | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use. | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly. | Class II | Terminated | |
| Z-0883-2021 | A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001 | A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality. | Class II | Terminated | |
| Z-0755-2021 | Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001 | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags. | Class II | Open, Classified | |
| Z-0754-2021 | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001 | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags. | Class II | Open, Classified | |
| Z-0804-2021 | CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001 | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results | Class II | Terminated | |
| Z-0803-2021 | CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo Catalog: 08468753001 | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results | Class II | Terminated | |
| Z-0752-2021 | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use | During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring). | Class II | Terminated | |
| Z-0634-2021 | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. | Class II | Terminated | |
| Z-0461-2021 | cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001 | Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule | Class II | Terminated | |
| Z-0086-2021 | DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001 | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket | Class II | Open, Classified | |
| Z-0085-2021 | BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket | Class II | Open, Classified | |
| Z-0104-2021 | Albumin Gen.2, Catalog 05166861190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. | Class III | Terminated | |
| Z-0103-2021 | Tina-quant Complement C4 ver.2, Catalog 05991994190 | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. | Class III | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Roche Diagnostics GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain