Alinity m System recalled for software defect in amplification detection
Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.
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 with a functional defect affecting diagnostic instrument operation. While no illnesses or injuries have been reported, this represents a risk of harm through potential diagnostic inaccuracy, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Abbott Molecular, Inc. is recalling 742 units of the Alinity m System, Model 08N53-002, all serial numbers, worldwide.
The recall is due to a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. This defect may affect the proper operation of the instrument.
The affected devices have been distributed worldwide, including to the United States and more than 45 other countries. The FDA has assigned recall number Z-0462-2022 to this recall.
The recalled product
- Product
- Alinity m System, Part No. 08N53-002
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device
- Affected units
- 742
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 (3)
- Alinity m System
- Model 08N53-002
- all serial numbers
Distribution
Distribution scope not specified by the agency.
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