CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report

QFT TB Antigen Tube recalled by Qiagen Sciences

Qiagen Sciences is recalling QFT TB Antigen Tube, distributed in Georgia. The recall was initiated on 2 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCODE(S): a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016 b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016 c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016 d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016 e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016

Quantity recalledThe total amount of product distributed 152,900 Tubes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1230-2016
FDA event ID: 73384
Recalling firm: Qiagen Sciences, Germantown, MD
Classification: Class II
Status: Terminated
Recall initiated: 2 Feb 2016
FDA classified: 22 Mar 2016
Reported: 30 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

2 Feb 2016	Recall initiated by company
22 Mar 2016	Classified by FDA	+49 days
30 Mar 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was 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), Singapore, Turkey and South Africa.

Georgia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

CODE(S): a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016 b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016 c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016 d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016 e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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