Devices

BD GeneOhm VanR Assay

Model / Serial
441250 | 05T11042
Product Description
IVD: Clostridium difficile toxin A/B nucleic acid IVD, kit, nucleic acid technique (NAT); DNA-probe, Staph aureus; Vancomycin kit
Manufacturer
GeneOhm Sciences Canada, Inc.
1 Event
- Field Safety Notices about BD GeneOhm VanR Assay

Manufacturer

GeneOhm Sciences Canada, Inc.

Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
SATP

One device with a similar name

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Device Recall BD GeneOhm VanR Assay

Model / Serial
Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)
Distribution
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.
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.
Manufacturer
Becton Dickinson & Co.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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