Class II — Potential Health Hazard

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

QFT TB Antigen Tube. QIAGEN Sciences Recalled by Qiagen Sciences LLC Due to Potential for obtaining a false positive result due...

Date: February 2, 2016
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

QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

Quantity: The total amount of product distributed 152,900 Tubes

Why Was This Recalled?

Potential for obtaining a false positive result due to the possibility of endotoxin presence.

Where Was This Sold?

Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.

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