FDA recall Z-1450-2022

Product

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.

Distribution

Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.

Key facts

Status

Terminated

Initiation date

2022-06-24

Report date

2022-07-27

Termination date

2024-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1450-2022