Becton Dickinson & Co.: Medical Device Recall in 2012 - (Recall #: Z-2320-2012)

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 VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.

Product Classification:

Class II

Date Initiated: May 22, 2012

Date Posted: September 12, 2012

Recall Number: Z-2320-2012

Event ID: 62505

Reason for Recall:

Leakage in Cepheid SmartCycler reaction tubes.

Status: Terminated

Product Quantity: 5 kits

Code Information:

Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)

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