Device Recall DRI Cocaine Metabolite Assay, Multigent Cocaine Assay

  • Model / Serial
    Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 10014593, lot number 60112588, Exp 2/29/2016; - not distributed Part number #l40-20, lot number 24215M500, Exp 8/13/14.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL
  • Product Description
    DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. || 100 ml, IVD || Mfg by: || Microgenics Corporation, || 46360 Fremont Blvd. || Fremont, CA 94538 || The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Microgenics Corp, 46360 Fremont Blvd, Fremont CA 94538-6406
  • Manufacturer Parent Company (2017)
  • Source
    USFDA