LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
LumiraDx
Reason for Recall:
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

Product Codes/Lot Numbers:

No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).

Distribution:

Distributed in: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1451-2022

Related Recalls

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

Sep 23, 2022 Diagnostic Equipment Nationwide View Details →