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.
This recall has been terminated (originally issued January 17, 2014).
- Recall Initiated
- October 11, 2013
- Posted
- January 17, 2014
- Terminated
- February 19, 2014
- Recall Number
- Z-0790-2014
- Quantity
- 33 kits
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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
US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
Lot / Code Info
Lot 08T13108 Exp Dec 24 2013
Root Cause
Error in labeling
Action Taken
Becton Dickinson sent an Urgent Product Recall Letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They were advised that a portion of the BD GeneOhm Cdiff assay test kits from one lot, 08T13108, may contain incorrect bags of sample buffer tube. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was discarded. Please fax to 410-316-4258.