Qiagen Sciences LLC recalls QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection

Recalled March 30, 2016 · FDA recall Z-1230-2016 · Qiagen Sciences

Hazard

Potential for obtaining a false positive result due to the possibility of endotoxin presence. · FDA Class II

Units

The total amount of product distributed 152,900 Tubes

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Qiagen Sciences LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →