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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 Device Recall Remel X/pect Clostridium Difficile Toxin A/B (20 tests)see related information
Date Initiated by FirmAugust 20, 2012
Date PostedFebruary 12, 2013
Recall Status1 Terminated 3 on June 04, 2013
Recall NumberZ-0806-2013
Recall Event ID 63558
Product Classification Reagents, clostridium difficile toxin - Product Code LLH
ProductRemel 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 KS 66215-3519
For Additional Information Contact
913-888-0939
Manufacturer Reason
for Recall		The firm is recalling the products due to a potential for false negative test results.
FDA Determined
Cause 2		Material/Component Contamination
ActionThermo 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 Commerce493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
DistributionWorldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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