Z-1230-2016Class II

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

Name: Z-1230-2016 QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis...
Creator: Qiagen Sciences LLC
Published: 2016-02-02
License: https://open.fda.gov/license/

Qiagen / initiated 2016-02-02 / Terminated / root cause: manufacturing process

FDA source

Qiagen Sciences LLC began a recall of QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease) on 2016-02-02. FDA classified it as Class II and gives the reason as "Potential for obtaining a false positive result due to the possibility of endotoxin presence". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1230-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-02
Posted: 2016-03-22
Terminated: 2016-08-16
Recalling firm: Qiagen
Product: QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Product code: NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
Reason for recall: Potential for obtaining a false positive result due to the possibility of endotoxin presence.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: [email protected] or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.
Quantity in commerce: The total amount of product distributed 152,900 Tubes
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1230-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1230-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-22

Product code NCD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)