Drugs & medicalClass II

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

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

Read the official notice →
Date
2022-07-27
Country
United States
Brand
LumiraDx
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Classification
Class II
Units
Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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