Reported Oct 20, 2021 · Terminated
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification…
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 (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
- Lot codes and dates
- List Number
09N78-095UDI 00884999049222Lot/Serial
- Expiration511810, 09/18/2021; 512026, 09/21/2021; 512900, 10/14/2021; 513146, 10/14/2021; 513583, 11/18/2021; 513959, 11/23/2021; 514176, 11/23/2021; 514216, 12/01/2021; 514819, 12/17/2021; 515052, 01/05/2022; 515653, 01/28/2022; 515949, 02/05/2022; 516085, 02/11/2022; 516611, 02/22/2022; 517139, 03/01/2022; 517355, 03/08/2022; 517999, 03/19/2022; 518266, 03/22/2022; 518435, 03/22/2022; 522689, 09/14/2022; 518670, 04/01/2022; 522691, 09/14/2022; 519124, 05/03/2022; 523309, 09/13/2022; 519583, 05/11/2022; 523468, 09/23/2022; 519785, 05/18/2022; 523621, 10/01/2022; 519968, 05/25/2022; 523946, 10/08/2022; 520216, 06/08/2022; 524203, 10/21/2022; 520699, 06/30/2022; 524438, 10/25/2022; 521106, 07/13/2022; 525862, 12/16/2022; 521654, 07/23/2022; 526394, 12/30/2022; 521842, 07/27/2022; 526484, 01/14/2023; 521857, 07/27/2022; 527399, 01/28/2023; 527400, 01/28/2023; 527540, 02/04/2023; 528026, 02/18/2023; List File 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo
- List Number
- Amount recalled
- 60563 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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