Reported Dec 28, 2022 · Ongoing
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
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?
Abbott Alinity m Resp-4-Plex Amp KitPart Number 09N79-090
- Lot codes and dates
- Lot Numbers381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp
- Amount recalled
- 12116 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
This product could cause temporary or reversible health problems — stop using it.
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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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