Reported Jan 12, 2022 · Terminated
Alinity m System, Part No. 08N53-002
Abbott Molecular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Molecular, Inc. · 1300 E Touhy Ave · Des Plaines, IL · 60018-3315
Is this the product you have?
- Alinity m System, Part No. 08N53-002
- Lot codes and dates
- Alinity m System, Model 08N53-002, all serial numbers
- Amount recalled
- 742 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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