Abbott Molecular, Inc.
Des Plaines, IL, US
ABBOTT MOLECULAR, INC. appears in FDA device records in Des Plaines, IL. FDA records list 19 510(k) clearances between and , 244 PMA records and one registered establishment. As of , FDA records show 47 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 19 510(k) clearances for Abbott Molecular, Inc. between 2008 and 2025. The busiest year on record is 2025, with 6. The most recent is 2025, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252102 | Alinity m HCV | MZP | Substantially Equivalent | |
| K243489 | Alinity m EBV (09N43-095) | QLX | Substantially Equivalent | |
| K243485 | Alinity m CMV | PAB | Substantially Equivalent | |
| K241921 | Alinity m BKV | QMI | Substantially Equivalent | |
| K241573 | Alinity m Resp-4-Plex | QOF | Substantially Equivalent | |
| K243410 | simpli-COLLECT STI Test | QYA | Substantially Equivalent | |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | QQX | Substantially Equivalent | |
| K233349 | Alinity m HSV 1 & 2 / VZV | PGI | Substantially Equivalent | |
| K222379 | Alinity m STI Assay | QEP | Substantially Equivalent | |
| K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) | QLX | Substantially Equivalent | |
| K202977 | Alinity m STI Assay | QEP | Substantially Equivalent | |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG | LSL | Substantially Equivalent | |
| K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT | PFG | Substantially Equivalent | |
| DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) | PDO | Unknown | |
| K091960 | VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 | OWK | Substantially Equivalent | |
| K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 | OVQ | Substantially Equivalent | |
| K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 | OOI | Substantially Equivalent | |
| K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 | LSK | Substantially Equivalent | |
| K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT | MKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005248192 | 3005248192 | ABBOTT MOLECULAR, INC. | 1300 EAST TOUHY AVENUE, Des Plaines, IL 60018 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KXGApplicator, Absorbent Tipped, Sterile
- OBFAssay, Genotyping, Hepatitis C Virus
- MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- KIRCells, Animal And Human, Cultured
- OVQChronic Lymphocytic Leukemia Fish Probe Kit
- JJHClinical Sample Concentrator
- PABCytomegalovirus (Cmv) Dna Quantitative Assay
- LIODevice, Specimen Collection
- PFGDna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia
- OYUDna-Probe Kit, Human Chromosome
- OXPDna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
- LSKDna-Reagents, Chlamydia
- LSFDna-Reagents, Epstein-Barr Virus
- LSLDna-Reagents, Neisseria
- OWKEarly Growth Response 1 (Egr) Fish Probe Kit
- PDOEarly Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
- PNKFluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
- PPMGeneral Purpose Reagent
- MKTHepatitis Viral B Dna Detection
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- QUMHuman Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
- MAQKit, Dna Detection, Human Papillomavirus
- NBGMarker, Colon
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- QMINucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
- QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- QTPReagents, Monkeypox Virus Nucleic Acid.
- MVUReagents, Specific, Analyte
- POAReagents, Zika Virus Nucleic Acid
- OOIReal Time Nucleic Acid Amplification System
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- OWDSomatic Gene Mutation Detection System
- KEYStainer, Tissue, Automated
- JQWStation, Pipetting And Diluting, For Clinical Use
- QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- NTHSystem, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
- NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence
- MZFTest, Hiv Detection
- OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System
- OHZUrine Transport Kit (Excludes Hiv Testing)
Recall records
Showing 25 of 47| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1749-2025 | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19. | There were reports of an increase in reactive negative controls and false positive results. | Class II | Open, Classified | |
| Z-1748-2025 | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection | There were reports of an increase in reactive negative controls and false positive results. | Class II | Open, Classified | |
| Z-1665-2025 | The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished). | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user. | Class II | Open, Classified | |
| Z-0234-2025 | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091; | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System. | Class II | Open, Classified | |
| Z-0233-2025 | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091 | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System. | Class II | Open, Classified | |
| Z-1602-2024 | Alinity m System, Part Number: 08N53-002 | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue. | Class II | Open, Classified | |
| Z-1190-2024 | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.) | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. | Class III | Open, Classified | |
| Z-1189-2024 | In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022; | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. | Class III | Open, Classified | |
| Z-1188-2024 | In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020; | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. | Class III | Open, Classified | |
| Z-0407-2024 | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma. | Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. | Class II | Open, Classified | |
| Z-1009-2023 | Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction. | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured. | Class II | Open, Classified | |
| Z-0740-2023 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. | Class II | Open, Classified | |
| Z-0739-2023 | Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. | Class II | Open, Classified | |
| Z-1349-2023 | Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results. | Class II | Open, Classified | |
| Z-0268-2023 | Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use | Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the flapper had previously been moved out of position. 2) Sample preparation drawer #1 barcode information is used instead of sample prep drawer #2 when the scanned data is not sent to the System Control Center before the next bottle barcode in sample prep drawer#2 is scanned. 3) Under a specific condition, while the system is processing tests and a new test request is made, when the level of the bulk solution is too low to process a test, the software would error stop the system and try to complete all in-process tests. An internal counter is reset which can cause reaction vessels (RVs) already present in an Amplification Detection Unit (or amp detect) to remain there and not be moved to waste so that more RVs can be placed into the amp detect for processing. 4) 4 to 6 replicates of the same auto calibrator orders can be run with 2 different sets of calibrator materials on the same rack. It was discovered during internal testing, when running 4 to 6 replicates of a calibrator, it is possible for the user to use 2 separate lots of material which is not detected by the System Control Center (SCC). If this were to occur, the calibration curve would be created using 2 separate material lots. In normal use scenario, this curve would be made using only 1 lot of material. | Class II | Open, Classified | |
| Z-1679-2022 | Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use. | Reports received of an increase of message code 9186 (internal control failed) when using the kit. | Class II | Open, Classified | |
| Z-1518-2022 | The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. | Incorrect optical calibration | Class II | Completed | |
| Z-0884-2022 | Alinity m HBV AMP Kit (US and CE) | There is a potential for misquantitation high results for negative samples. | Class II | Open, Classified | |
| Z-0883-2022 | Alinity m HBV Application Specification File (US and CE) | There is a potential for misquantitation high results of negative samples. | Class II | Open, Classified | |
| Z-0710-2022 | Alinity m Integrated Reaction Units (IRU) | There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. | Class II | Terminated | |
| Z-0463-2022 | Alinity m System, Part No. 08N53-002 | There is an issue with the installation of updated camera firmware on the system. | Class II | Terminated | |
| Z-0462-2022 | Alinity m System, Part No. 08N53-002 | There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. | Class II | Open, Classified | |
| Z-0461-2022 | Alinity m System, Part No. 08N53-002 | There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. | Class II | Open, Classified | |
| Z-0460-2022 | Alinity m System, Part No. 08N53-002 | There is a potential for abnormal (non-sigmoidal) amplification curves. | Class II | Open, Classified | |
| Z-0008-2022 | Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic | There is a potential for false positive results. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain