Recall Z-2316-2012 ยท LLH Reagents, Clostridium Difficile Toxin
Becton Dickinson & Co.
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended t
| 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 | 38 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
| K093346 | BD GENEOHM MRSA ACP ASSAY Bd Diagnostics (Geneohm Sciences, Inc.), Dec 15, 2009 |