Z-2316-2012 Class II Terminated
FDA device recall Z-2316-2012 was initiated by Becton Dickinson & Co. on May 22, 2012 and is designated Class II. Reason for recall: Leakage in Cepheid SmartCycler reaction tubes. The recall status is terminated (terminated Nov 2, 2012). Affected quantity: 38 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 12, 2012
- Initiation Date
- May 22, 2012
- Termination Date
- Nov 2, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 kits
Product Description
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 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.
Reason for Recall
Leakage in Cepheid SmartCycler reaction tubes.
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.
Code Information
Lot/Exp date: 03T11346Z 2012-06-11, 03T12034 2012-07-31
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2316-2012
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026