Qiagen QFT TB Antigen Tubes Recalled for Potential Endotoxin Contamination
Qiagen is recalling QFT TB Antigen Tubes due to potential endotoxin presence that could cause false positive results in tuberculosis tests.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (false positive medical results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Qiagen Sciences LLC is recalling QFT TB Antigen Tubes, which are components of the QuantiFERON TB-Gold test used to detect M. tuberculosis infection. The recall is due to the potential presence of endotoxin in the product, which may lead to false positive test results.
The recall affects 152,900 tubes distributed worldwide, including in the United States (specifically Georgia) and various countries in Europe, Asia, and Africa. Specific lot numbers and expiration dates are listed in the agency's structured data.
Healthcare providers and patients should stop using the affected lots and contact Qiagen for further instructions or replacements. The FDA has classified this as a Class II recall.
The recalled product
- Product
- QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 152,900
Distribution
Distributed in 1 state:
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