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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