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U.S. Department of Health and Human Services

Class 2 Device Recall Remel X/pect Clostridium Difficile Toxin A/B (20 tests)

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 Class 2 Recall
Remel X/pect Clostridium Difficile Toxin A/B (20 tests)
see related information
Date Posted February 12, 2013
Recall Status1 Terminated on June 04, 2013
Recall Number Z-0806-2013
Recall Event ID 63558
Premarket Notification
510(K) Number
K041951 
Product Classification Reagents, Clostridium Difficile Toxin - Product Code LLH
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.
Code Information Lots: 082505; 131988; 131994
Recalling Firm/
Manufacturer
Remel Inc
12076 Santa Fe Trail Dr
Lenexa, Kansas 66215-3519
Manufacturer Reason
for Recall
The firm is recalling the products due to a potential for false negative test results.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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).
Quantity in Commerce 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
Distribution Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLH and Original Applicant = REMEL INC
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