Qiagen Sciences LLC: Medical Device Recall in 2016 - (Recall #: Z-1230-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 2, 2016

Date Posted: March 30, 2016

Recall Number: Z-1230-2016

Event ID: 73384

Reason for Recall:

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

Status: Terminated

Product Quantity: The total amount of product distributed 152,900 Tubes

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated