LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Reported: July 27, 2022 Initiated: June 24, 2022 #Z-1450-2022
Product Description
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Reason for Recall
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Details
- Recalling Firm
- LumiraDx
- Units Affected
- 635 units
- Distribution
- Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip. Recalled by LumiraDx. Units affected: 635 units.
Why was this product recalled? ▼
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2022. Severity: Moderate. Recall number: Z-1450-2022.
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