Reported Jul 27, 2022 · Terminated
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
LumiraDx
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: LumiraDx · 221 Crescent St · Waltham, MA · 02453-3475
Is this the product you have?
- LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
- Lot codes and dates
- No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022).
- Amount recalled
- 635 units
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
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
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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