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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65883
Product Type Devices
Status Ongoing
Recalling Firm Microgenics Corp
City Fremont
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-23
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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 Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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. Class II Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation. 1473 units in distribution. Z-2267-2013
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