LumiraDx: Medical Device Recall in 2022 - (Recall #: Z-1450-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

Product Classification:

Class II

Date Initiated: June 24, 2022

Date Posted: July 27, 2022

Recall Number: Z-1450-2022

Event ID: 90479

Reason for Recall:

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

Status: Terminated

Product Quantity: 635 units

Code Information:

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).

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated