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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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