The FDA announced on 2022-10-12 that Abbott Molecular, Inc. is recalling the Alinity m System (REF 08N53-002) due to potential software performance issues. The agency classified the recall as Class II and ongoing.
How to tell if you have it
- Brand: Abbott
- Product: Alinity m System
- Reference Number: REF 08N53-002
- Use: For In Vitro Diagnostic Use
- Serial Numbers: All serial numbers
The hazard
The FDA said the software version 1.6.5 may cause the waste chute flapper to remain closed, use incorrect barcode information from sample preparation drawers, error stop the system due to low bulk solution levels, or allow calibration curves to be created using two separate material lots instead of one.
Context
GovInfoNow's records show Abbott Molecular, Inc. has had 19 other recalls since 2021-08-04. Recent similar recalls include the Abbott Alinity m Resp-4-Plex AMP Kit recall on 2025-04-28 for false positive results risk, the Abbott Alinity m System recall on 2025-03-20 for liquid spill hazard, and the Abbott Alinity m HPV Kit recall on 2024-09-12 for Error Code 9198 risk. Other recent recalls of similar products include the Abbott Medical Merlin PCS 365 recall on 2026-05-12 for software malfunction risks, the Roche cobas pro integrated solutions recall on 2026-01-20 for incorrect lab results, and the Abbott ID NOW Influenza A & B 2 Kit recall on 2026-02-09 for higher invalid rates risk.