Reported Aug 24, 2022 · Completed
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
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?
- The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
- Lot codes and dates
- Serial Number 00654
- Amount recalled
- 1
Why it was recalled
Incorrect optical calibration
This product could cause temporary or reversible health problems — stop using it.
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