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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device with potential for component detachment during transport. No illnesses or injuries have been reported, but the defect poses a theoretical risk to diagnostic test integrity and laboratory operations, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Molecular, Inc. is recalling 3063 kits of Alinity m Integrated Reaction Units (IRU) used in laboratory diagnostic testing. The recall affects units distributed nationwide across 22 U.S. states.
The reaction vessels (RVs) in these units have the potential to detach from the reaction unit cap during transport by the pipettor robot. This defect could compromise the integrity of diagnostic tests performed with affected units.
Laboratories and healthcare facilities using the recalled lot numbers (766233, 770433, 771200, 771201, and 773642) should contact Abbott Molecular for replacement or further instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Alinity m Integrated Reaction Units (IRU)
- Manufacturer
- Abbott Molecular, Inc.
- Affected units
- 3,063
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- List Number 09N26-010
Distribution
Related recalls
Same manufacturer · Abbott Molecular, Inc.
See all →- HighAbbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall
FDA (Devices) · 2025-05-21
- HighAbbott Alinity m Resp-4-Plex Amplification Kit Recall
FDA (Devices) · 2025-05-21
- ModerateAlinity m System nucleic acid testing instruments recalled for liquid spillage
FDA (Devices) · 2025-04-30
- HighAbbott Alinity m HPV test kit control failures from iron contamination
FDA (Devices) · 2024-11-06
- HighAbbott STI and HPV Test Kits Recalled for Quality Control Failures
FDA (Devices) · 2024-11-06
Same hazard · component detachment
See all →- ModerateGalt Medical Recalls Boston Scientific Transcarotid Access Kits
FDA (Devices) · 2026-08-19
- ModerateALYON surgical light head intensity control buttons may detach
FDA (Devices) · 2026-06-24
- ModerateHarmonyAIR A-Series surgical light intensity control buttons may detach
FDA (Devices) · 2026-06-24
- SevereForest River trailer shock bolts may break and detach onto the road
NHTSA · 2026-05-26
- SevereFord Bronco hardtop roof panel sections may separate and detach
NHTSA · 2026-05-12