LumiraDx: Medical Device Recall in 2022 - (Recall #: Z-0135-2023)

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 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

Product Classification:

Class III

Date Initiated: September 23, 2022

Date Posted: November 2, 2022

Recall Number: Z-0135-2023

Event ID: 90998

Reason for Recall:

Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC

Status: Terminated

Product Quantity: 83 kits

Code Information:

LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated