LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quali

FDA device recall Z-0135-2023 · posted 2022-10-26 · Terminated

Recall details

Recalling firm

LumiraDx

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

Action taken

LumiraDx issued Urgent Product Recall Notice and were provided with an attestation form to document product destruction at their facility via email on 23 September 2022. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lots of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls. " Remove from your stock any remaining affected kits of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls as listed in Table 1. " Ensure any of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls are removed from your inventory are destroyed (not just thrown away), indicate the number of Liquid Quality Control kits that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls in your inventory. " Report any issues or adverse events with using the LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product over the course of the next few days. If you have any questions, contact LumiraDx Customer Services at customerservices.US@lumiradx.com or 1-888-586-4721.

Root cause

Error in labeling

Status

Terminated

Product code

QKP

Quantity affected

83 kits

Distribution

US Nationwide distribution.

Date initiated

2022-09-23

Date posted

2022-10-26

Date terminated

2024-12-13

Location

Waltham, MA