Class 2 Device Recall BD GeneOhm Cdiff Assay

• Date Initiated by Firm: October 11, 2013
• Date Posted: January 17, 2014
• Recall Status: Terminated on February 19, 2014
• Recall Number: Z-0790-2014
• Recall Event ID: 66933
• 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 MD 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: 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 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.

• 510(K) Database: 510(K)s with Product Code = LLH