FDADecember 6, 2021device
Alinity m System, Part No. 08N53-002
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
What to do
FDA enforcement status: Ongoing
Brands named
abbott molecularabbott
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDAi-STAT EG6+ cartridge; List Number: 03P77-25;2026-04-01
- FDAi-STAT G3+ cartridge; List Number: 03P78-26;2026-04-01
- FDAi-STAT EG7+ cartridge; List Number: 03P76-25;2026-04-01
- FDAProduct Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable2026-02-09
- FDAFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
- FDAFreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
- FDAFreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.2025-11-24
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