Reported Mar 30, 2016 · Terminated

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

Qiagen Sciences LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415

Is this the product you have?

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

5 of 5 products

Products covered by this recall
Model / numberProduct as published
0592-0201Lot #A150135A TB Antigen Tube Expiry: April 2016
0590-0201Lot #059061291 TB-Nil 200pk Expiry: April 2016
0597-0201Lot #059772271 SPP Expiry: April 2016
0597-0701Lot #059772281 SPP-Luer Expiry: April 2016
622686Lot #059087361 TB-Nil 200 PK Expiry: April 2016
Amount recalled
The total amount of product distributed 152,900 Tubes

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 16, 2016 · Data as of Sep 19, 6:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.