Becton Dickinson & Co.: Medical Device Recall in 2012 - (Recall #: Z-2317-2012)

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 MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .

Product Classification:

Class II

Date Initiated: May 22, 2012

Date Posted: September 12, 2012

Recall Number: Z-2317-2012

Event ID: 62505

Reason for Recall:

Leakage in Cepheid SmartCycler reaction tubes.

Status: Terminated

Product Quantity: 68 kits

Code Information:

Lot/ Exp. 03T11345ZU 2012-07-09

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