Abbott Alinity m System Molecular Diagnostic Device Amplification Defect Recall
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
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 device with potential for abnormal test results and no reported illnesses or injuries. Classified as high due to the risk of diagnostic inaccuracy in a medical device, per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Molecular, Inc. is recalling 742 Alinity m System (Model 08N53-002, all serial numbers) diagnostic devices distributed worldwide. The devices are used for molecular testing and analysis.
The recall was initiated because the affected devices have a potential for abnormal (non-sigmoidal) amplification curves during operation. This defect could compromise the accuracy of diagnostic test results.
The affected devices were distributed worldwide, including throughout the US and to 46 additional countries including Australia, Canada, Japan, the United Kingdom, and others.
Customers currently using the affected devices should contact Abbott Molecular, Inc. for instructions on remediation or replacement.
The recalled product
- Product
- Alinity m System, Part No. 08N53-002
- Manufacturer
- Abbott Molecular, Inc.
- 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 (2)
- Model 08N53-002
- all serial numbers
Distribution
Distributed nationwide across the United States.
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