Reported Apr 13, 2022 · Ongoing
Alinity m HBV AMP Kit (US and CE)
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 HBV AMP Kit (US and CE)
- Lot codes and dates
- List Numbers1) 08N47-095 (US)
- Lots
519756523799and 524361
- Updated to add
3815835293915296875302735315982) 08N47-090 (CE)
- Lots
519755520957522137523798and 524059
- Updated to add
380963380979381021529378529686530272531189531596
- Amount recalled
- 4966 kits, updated 101/17/2023
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There is a potential for misquantitation high results for negative samples.
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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