Reported Oct 20, 2021 · Terminated
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application…
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 Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
- Lot codes and dates
- List Number
09N79-096UDI 00884999049390Lot/Serial
- Expiration514074, 09/15/2021; 519243, 05/10/2022; 519243, 5/10/2022; 522088, 8/4/2022; 522128, 8/26/2022; 523152, 10/10/2022; 524433, 1/15/2023; 526710, 1/21/2023; 527845, 2/8/2023; List Number 09N79-05D, UDI (01) 00884999050242(240 )09N79-05D(8012)4.oo
- List Number
- Amount recalled
- 8469 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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