—#114203

Product

Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

FDA product code: LLH — Reagents, Clostridium Difficile Toxin
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lots: 082505; 131988; 131994

Why it was recalled

The firm is recalling the products due to a potential for false negative test results.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Thermo Fisher sent a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were requested to follow the instructions provided and fax back the attached "Acknowledgement & Receipt Form" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190 (International). For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom

Timeline

Recall initiated: 2012-08-20
Posted by FDA: 2013-02-12
Terminated: 2013-06-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.