Becton Dickinson & Co.: Medical Device Recall in 2012 - (Recall #: Z-2318-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 22, 2012

Date Posted: September 12, 2012

Recall Number: Z-2318-2012

Event ID: 62505

Reason for Recall:

Leakage in Cepheid SmartCycler reaction tubes.

Status: Terminated

Product Quantity: 57 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated