Reported Oct 20, 2021 · Terminated
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Abbott Molecular, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Lot codes and dates
- List Number
09N78-090UDI UDI 00884999049222Lot/Serial
- Expiration
100 of 100 codes
51146809/15/202151150409/15/202151150509/15/202151202509/21/202151241609/18/202151241709/18/202151270509/21/202151271210/07/202151289810/07/202151314710/14/202151362911/18/202151435912/01/202151476212/17/202151505301/05/202251541501/15/202251541601/15/202251594801/28/202251608402/05/202251643002/17/202251643102/18/202251661202/25/202251663603/01/202251691003/04/202251691102/11/202251700902/18/202251713802/25/202251735403/08/202251787603/19/202251799803/19/202251866804/01/2022
- List Number09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo
- List Number
- Amount recalled
- 71314 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a potential for false positive results.
Using this product could cause serious injury, illness or death — stop using it now.
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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