Recall Z-0807-2013

Remel Inc · initiated August 20, 2012

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product 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.

Codes / lots: Lot 141764

Reason for recall

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

FDA-determined cause: Material/Component Contamination

Action taken

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).

Details

Recall number
Z-0807-2013
Initiated
August 20, 2012
Posted by FDA
February 12, 2013
Terminated
June 4, 2013
Product code
LLH – Reagents, Clostridium Difficile Toxin
Quantity
50 units
Distribution
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Recalling firm
Remel Inc, Lenexa, KS

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0806-2013 Class IIRemel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B…The firm is recalling the products due to a potential for false negative test results. 08/20/2012Terminated