LumiraDx SARS-CoV-2 Antibody recall
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Why was LumiraDx SARS-CoV-2 Antibody recalled?
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
- Recalling firm
- LumiraDx
- Quantity
- 635 units
- Distribution
- Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)