Recall Z-2318-2012 ยท LLH Reagents, Clostridium Difficile Toxin
Becton Dickinson & Co.
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 (
| Date | Sep 6, 2012 (initiated May 22, 2012) |
| Status | Terminated |
| Reason | Leakage in Cepheid SmartCycler reaction tubes. |
| Root cause | 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: RegulatoryC |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081920 | BD GENEOHM CDIFF ASSAY Bd Diagnostics (Geneohm Sciences, Inc.), Dec 19, 2008 |