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U.S. Department of Health and Human Services

Class 2 Device Recall BD GeneOhm Cdiff Assay

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 Class 2 Recall
BD GeneOhm Cdiff Assay
see related information
Date Posted January 17, 2014
Recall Status1 Terminated on February 19, 2014
Recall Number Z-0790-2014
Recall Event ID 66933
Premarket Notification
510(K) Number
K081920 
Product Classification Reagents, Clostridium Difficile Toxin - Product Code LLH
Product BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.
Code Information Lot 08T13108 Exp Dec 24 2013
Recalling Firm/
Manufacturer
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks, Maryland 21152-0999
For Additional Information Contact Gail Claiborne
410-316-4054
Manufacturer Reason
for Recall
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Becton Dickinson sent an Urgent Product Recall Letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They were advised that a portion of the BD GeneOhm Cdiff assay test kits from one lot, 08T13108, may contain incorrect bags of sample buffer tube. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was discarded. Please fax to 410-316-4258.
Quantity in Commerce 33 kits
Distribution US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
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 = BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
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