Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SARS-CoV-2 Antigen Test Recalled by Qiagen Sciences LLC Due to QIAGEN has become aware of the potential for...

Date: January 15, 2021
Company: Qiagen Sciences LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Qiagen Sciences LLC directly.

Affected Products

SARS-CoV-2 Antigen Test

Quantity: 1092 boxes of 60 (65,520 e-sticks)

Why Was This Recalled?

QIAGEN has become aware of the potential for false positive results to occur with some patient samples.

Where Was This Sold?

This product was distributed to 19 states: AZ, CA, CO, FL, HI, IL, KY, MI, MO, NJ, NM, NY, NC, OH, RI, TX, WA, WY, DC

Affected (19 states)Not affected

About Qiagen Sciences LLC

Qiagen Sciences LLC has 21 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report