LumiraDx recalls SARS-CoV-2 Antigen Liquid Quality Control Kits with incorrect vial lot numbers that may prevent proper testing. Affected kits could show error messages and fail to function correctly.
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
LumiraDx is recalling SARS-CoV-2 Antigen Liquid Quality Control Kits that have incorrect vial lot numbers. This error may cause the kits to display an error message and prevent proper testing, potentially leading to inaccurate results.
The vial lot numbers for the SARS-CoV-2 Antigen Liquid Quality Control Kits were incorrectly assigned. This error causes the kits to show an error message and prevent use, which could lead to inaccurate test results if used.
Users of the LumiraDx SARS-CoV-2 Antigen Liquid Quality Control Kits with the specific lot numbers mentioned in the recall. Laboratory personnel testing for SARS-CoV-2 are most at risk of inaccurate results.
Check the vial lot numbers on the kit: Positive Control Vial: 1000 1710 0014 0141 and Negative Control Vial: 1000 1720 0014 0142. The kits were sold with batch number 2002204017 and expire on March 1, 2023.
Verify the vial lot numbers on the kit: Positive Control Vial: 1000 1710 0014 0141 and Negative Control Vial: 1000 1720 0014 0142.
LumiraDx SARS-CoV-2 Antigen Liquid Quality Control Kits with vial lot numbers 1000 1710 0014 0141 (positive) and 1000 1720 0014 0142 (negative) from batch 2002204017.
The vial lot numbers were incorrectly assigned, causing the kits to display an error message and prevent proper testing.
Check the vial lot numbers on your kit. If they match the recalled numbers, stop using it and contact LumiraDx for further instructions.
We’ve drafted a message you can send LumiraDx to request your refund or repair — edit it as you like.
Subject: Recall Z-0135-2023 — LumiraDx LumiraDx Hello, I own a LumiraDx that is covered by recall Z-0135-2023 from LumiraDx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
