The Recall Desk

Manufacturer

Abbott Molecular, Inc.

30 recalls in our database name Abbott Molecular, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
30
Critical
0
Severe
5
Most recent
2025-05-21

Of the 30 recalls from Abbott Molecular, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (17%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 30

  • HighFDA (Devices)·Z-1748-2025·2025-05-21

    Abbott Alinity m Resp-4-Plex Amplification Kit Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex Amplification Kit due to reports of reactive negative controls and false positive results in respiratory virus testing.

    Product
    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 (fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2025·2025-05-21

    Abbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit (List Number 09N79-096) due to reports of increased reactive negative controls and false positive results in respiratory viral testing.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1665-2025·2025-04-30

    Alinity m System nucleic acid testing instruments recalled for liquid spillage

    Abbott Molecular is recalling the Alinity m System due to a design flaw that may allow liquid waste or system solutions to spill beyond the instrument footprint into the user's walking path.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2025·2024-11-06

    Abbott STI and HPV Test Kits Recalled for Quality Control Failures

    Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.

    Product
    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;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2025·2024-11-06

    Abbott Alinity m HPV test kit control failures from iron contamination

    Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2024·2024-05-01

    Abbott Alinity m System camera generates error with certain tubes

    Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.

    Product
    Alinity m System, Part Number: 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1188-2024·2024-03-06

    Abbott in-vitro diagnostic kits shipped without U.S. approval or registration

    Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.

    Product
    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;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2024·2024-03-06

    Abbott M1000 Wash Station Shipped Without U.S. Approval or Registration

    Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.

    Product
    Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2024·2024-03-06

    Abbott Vysis Diagnostic Kits Recalled for U.S. Regulatory Non-Compliance

    Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.

    Product
    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,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2024·2023-12-06

    Abbott Alinity m HCV Kit Recalled for False Positive Results

    Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.

    Product
    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 hum
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1349-2023·2023-04-12

    Abbott Alinity m System Recall: Missing Components and Improper Calibration

    Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.

    Product
    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1009-2023·2023-02-01

    Abbott Alinity m System Nucleic Acid Testing Device Calibration Recall

    Abbott Molecular is recalling 918 Alinity m nucleic acid testing systems due to three identified potential calibration and configuration errors.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0739-2023·2022-12-28

    Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Test Results

    Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.

    Product
    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0740-2023·2022-12-28

    Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results

    Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.

    Product
    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0268-2023·2022-11-30

    Diagnostic System Software Defects Affecting Sample Processing and Test Accuracy

    Abbott is recalling 883 Alinity m diagnostic systems due to software defects affecting sample identification, system operation, and test calibration. The issues affect all serial numbers running software version 1.6.5.

    Product
    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1679-2022·2022-09-14

    Abbott Alinity m SARS-CoV-2 Control Kit Recalled for Failed Internal Control

    Abbott is recalling 579 kits of its Alinity m SARS-CoV-2 CTRL control kit after reports of failed internal control errors preventing verification of test accuracy.

    Product
    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.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1518-2022·2022-08-24

    Abbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration

    Abbott Molecular is recalling the Alinity m System due to incorrect optical calibration. The affected unit (Serial Number 00654) was distributed to Italy.

    Product
    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0883-2022·2022-04-13

    Abbott Alinity m HBV Device Misquantitation of Negative Samples

    Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.

    Product
    Alinity m HBV Application Specification File (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0884-2022·2022-04-13

    Alinity m HBV AMP Kit Recalled for Risk of Falsely High Test Results

    Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.

    Product
    Alinity m HBV AMP Kit (US and CE)
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0710-2022·2022-03-09

    Abbott Alinity m reaction units risk detachment during transport

    Abbott Molecular is recalling 3063 kits of Alinity m Integrated Reaction Units due to potential detachment of reaction vessels from the unit cap during transport. No injuries have been reported.

    Product
    Alinity m Integrated Reaction Units (IRU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2022·2022-01-12

    Alinity m System recalled for software defect in amplification detection

    Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0461-2022·2022-01-12

    Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures

    Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2022·2022-01-12

    Abbott Alinity m System camera firmware installation issue

    Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-0008-2022·2021-10-20

    Abbott Respiratory Diagnostic Kit Recalled for Potential False Positive Results

    Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.

    Product
    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide