Becton Dickinson & Co.: Medical Device Recall in 2014 - (Recall #: Z-0790-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 11, 2013

Date Posted: January 29, 2014

Recall Number: Z-0790-2014

Event ID: 66933

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.

Status: Terminated

Product Quantity: 33 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated