Recall Z-0790-2014 ยท LLH Reagents, Clostridium Difficile Toxin
Becton Dickinson & Co.
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 su
| Date | Jan 17, 2014 (initiated Oct 11, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 33 kits |
| Distribution | US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA. |
| 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 |