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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 September 06, 2012
Recall Status1 Terminated on November 02, 2012
Recall Number Z-2318-2012
Recall Event ID 62505
Premarket Notification
510(K) Number
K081920 
Product Classification Reagents, Clostridium Difficile Toxin - Product Code LLH
Product BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om 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. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
Code Information Lot/ Exp. 08T11248 2012-06-22, 08T11251 2012-06-26
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
Leakage in Cepheid SmartCycler reaction tubes.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action BD Diagnostic Systems issued an Urgent Product Recall letter via UPS overnight delivery on May 22, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue use and discard any affected product. BD would send replacement tubes for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance FAX: 410-316-4258 Email: RegulatoryComplianceFax@bd.com If further assistance is needed, customers should contact BD Technical Services Department at 1-800-838-8663. For questions regarding this recall call 410-316-4054.
Quantity in Commerce 57 kits
Distribution Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
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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