Z-2319-2012 Class II Terminated
FDA device recall Z-2319-2012 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: 32 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
- 32 kits
Product Description
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 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 from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
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. 08T11250 2012-07-06
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2319-2012
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026