Medical device recalls Moderate risk

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

Recall date
February 2, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1230-2016
FDA classification
Class II
Brand / firm
Qiagen Sciences LLC
Sold / distributed
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), Singa…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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