Recall Z-1230-2016— Qiagen Sciences LLC

Name: FDA recall Z-1230-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-02

Class II · Terminated

Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2016-02-02, terminated 2016-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease). Reason: Potential for obtaining a false positive result due to the possibility of endotoxin presence..

Recalling firm: Qiagen Sciences LLC
Classification: Class II
Status: Terminated
Initiated: 2016-02-02
Terminated: 2016-08-16
Firm location: Germantown, MD, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.