Device product
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B 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.
Z-0790-2014
Product summary
- Event
- Event 66933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 kits
- Official record key
device-enforcement:Z-0790-2014
Official wording
Reason: An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Code information: Lot 08T13108 Exp Dec 24 2013
Distribution pattern: US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
Derived failure modes
-
Unknown
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.