Recall Z-1450-2022— LumiraDx

Name: FDA recall Z-1450-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

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) Test Strip. 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) 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.