Recall Z-1451-2022— LumiraDx
Class II · Terminated
Class II FDA medical device recall by LumiraDx, initiated 2022-06-24, terminated 2024-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control. Reason: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA..
- Recalling firm
- LumiraDx
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-06-24
- Terminated
- 2024-05-10
- Firm location
- Waltham, MA, United States
Product description
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Reason for recall
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.