Enforcement Report - Week of September 12, 2012
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Product Detail
| Product Description | BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 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 to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. . |
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| Recall Number | Z-2317-2012 |
| Classification | Class II |
| Code Info | Lot/ Exp. 03T11345ZU 2012-07-09 |
| Product Distributed Qty | 68 kits |
| Reason For Recall | Leakage in Cepheid SmartCycler reaction tubes. |
Event Detail
| Event Id | 62505 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Becton Dickinson & Co. |
| City | Sparks |
| State | MD | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
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