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.
FDA Recall Z-2318-2012 · Posted 2012-09-06
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLLH
Date Initiated2012-05-22
Date Terminated2012-11-02
Product Quantity57 kits
Reason for Recall
Leakage in Cepheid SmartCycler reaction tubes.
Firm 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: [email protected]
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.