Z-1230-2016 Class II Terminated
FDA device recall Z-1230-2016 was initiated by Qiagen Sciences LLC on Feb 2, 2016 and is designated Class II. Reason for recall: Potential for obtaining a false positive result due to the possibility of endotoxin presence. The recall status is terminated (terminated Aug 16, 2016). Affected quantity: The total amount of product distributed 152,900 Tubes.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2016
- Initiation Date
- Feb 2, 2016
- Termination Date
- Aug 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- The total amount of product distributed 152,900 Tubes
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.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1230-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026