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 Recall Z-0806-2013 · Posted 2013-02-12
Advertisement
Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeLLH
Date Initiated2012-08-20
Date Terminated2013-06-04
Product Quantity493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
Reason for Recall
The firm is recalling the products due to a potential for false negative test results.
Firm Action
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).
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement