Sentinel CH SpA
MILANO Milano, IT
SENTINEL CH. SPA appears in FDA device records in MILANO Milano, IT. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Sentinel CH SpA between 2005 and 2025. The busiest year on record is 2005, with 8. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 8 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 2 |
| 2011 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242585 | Cystatin C | NDY | Substantially Equivalent | |
| K211058 | Lp(a) Ultra | DFC | Substantially Equivalent | |
| K193001 | Albumin BCP | CJW | Substantially Equivalent | |
| K192118 | CRP Vario | DCK | Substantially Equivalent | |
| K173833 | CRP Vario | NQD | Substantially Equivalent | |
| K141728 | ACE CALIBRATOR | JIT | Substantially Equivalent | |
| K102706 | CKMB UDR ASSAY | JHS | Substantially Equivalent | |
| K083602 | KAPPA LIGHT CHAINS | DFH | Substantially Equivalent | |
| K083601 | LAMBDA LIGHT CHAINS | DEH | Substantially Equivalent | |
| K081533 | SENTINEL PLASMAPROTEINS CAL 3X | JIX | Substantially Equivalent | |
| K073634 | MULTIGENT CREATININE (ENZYMATIC) ASSAY | JFY | Substantially Equivalent | |
| K070987 | SENTINEL LITHIUM ASSAY | NDW | Substantially Equivalent | |
| K070971 | MODIFICATION TO SENTINEL CLIN CHEM CAL | JIX | Substantially Equivalent | |
| K051447 | SENTINEL PANCREATIC AMYLASE | JFJ | Substantially Equivalent | |
| K051114 | SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY | JIF | Substantially Equivalent | |
| K051111 | SENTINEL UIBC LIQUID | JQF | Substantially Equivalent | |
| K051452 | SENTINEL CLIN CHEM CAL | JIX | Substantially Equivalent | |
| K051456 | SENTINEL CERULOPLASMIN | JFR | Substantially Equivalent | |
| K051115 | SENTINEL IRON LIQUID | JIY | Substantially Equivalent | |
| K050836 | CRP DIAGNOSTIC ASSAY | DCK | Substantially Equivalent | |
| K051457 | SENTINEL PLASMAPROTEINS CAL 3X | JIX | Substantially Equivalent | |
| K051444 | SENTINEL CHOLINESTERASE LIQUID | DIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681753 | 3000303338 | SENTINEL CH. SPA | VIA ROBERT KOCH, 2, MILANO 20152 IT | 2026 | and 17 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DLIAcetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- NDWAssay, Porphyrin, Spectrophotometry, Lithium
- JQFBathophenanthroline, Iron Binding Capacity
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control
- JFJCatalytic Methods, Amylase
- DIHColorimetry, Cholinesterase
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- JIFEnzymatic Method, Ammonia
- JFYEnzymatic Method, Creatinine
- HIHHysteroscope (And Accessories)
- JFRIndirect Copper Assay, Ceruloplasmin
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JIYPhotometric Method, Iron (Non-Heme)
- KQNRadioassay, Angiotensin Converting Enzyme
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- NDYTest, Cystatin C
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0326-2024 | Alinity c Iron Reagent, Reference Number 08P3920 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results. | Class II | Open, Classified | |
| Z-0325-2024 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results. | Class II | Open, Classified | |
| Z-0033-2022 | Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer. | Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully. | Class III | Terminated | |
| Z-2012-2021 | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001 | Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users. | Class III | Open, Classified | |
| Z-2552-2019 | Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320 | Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results | Class II | Terminated | |
| Z-2551-2019 | MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30 | Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results | Class II | Terminated | |
| Z-2867-2017 | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2 | Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration. | Class II | Terminated | |
| Z-0164-2016 | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma. | Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain