Z-0790-2014 Class II Terminated
FDA device recall Z-0790-2014 was initiated by Becton Dickinson & Co. on Oct 11, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Feb 19, 2014). Affected quantity: 33 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 29, 2014
- Initiation Date
- Oct 11, 2013
- Termination Date
- Feb 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 kits
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
Code Information
Lot 08T13108 Exp Dec 24 2013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0790-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026