Recall Z-2267-2013— Microgenics Corp

Name: FDA recall Z-2267-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-23

Class II · Terminated

Class II FDA medical device recall by Microgenics Corp, initiated 2013-07-23, terminated 2013-12-02. It names one FDA 510(k) clearance: K960187. Product: 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.. Reason: 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..

Recalling firm: Microgenics Corp
Classification: Class II
Status: Terminated
Initiated: 2013-07-23
Terminated: 2013-12-02
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K960187 — COCAINE METABOLITE EIA TESTDiagnostic Reagents, Inc.·cleared 1996-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.