Device product
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 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 fr.om 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.
Z-2318-2012
Product summary
- Event
- Event 62505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57 kits
- Official record key
device-enforcement:Z-2318-2012
Official wording
Reason: Leakage in Cepheid SmartCycler reaction tubes.
Code information: Lot/ Exp. 08T11248 2012-06-22, 08T11251 2012-06-26
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.
Derived failure modes
-
Unknown
Leakage in Cepheid SmartCycler reaction tubes.