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Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

FDA Device Recall #Z-0268-2023 — Class II — October 12, 2022

Recall Summary

Recall Number Z-0268-2023
Classification Class II — Moderate risk
Date Initiated October 12, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Abbott Molecular, Inc.
Location Des Plaines, IL
Product Type Devices
Quantity 883 units

Product Description

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Reason for Recall

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.

Distribution Pattern

Worldwide distribution.

Lot / Code Information

All serial numbers

Other Recalls from Abbott Molecular, Inc.

Recall # Classification Product Date
Z-1749-2025 Class II Alinity m Resp-4-Plex AMP Kit, List Number 09N7... Apr 28, 2025
Z-1748-2025 Class II Alinity m Resp-4-Plex Amplification (AMP) Kit (... Apr 28, 2025
Z-1665-2025 Class II The Alinity m System is designed to automate th... Mar 20, 2025
Z-0233-2025 Class II Abbott Alinity m HPV AMP Kit, used with the Ali... Sep 12, 2024
Z-0234-2025 Class II Abbott Alinity m STI AMP Kit, used with the Ali... Sep 12, 2024

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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