Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DRI Cocaine Metabolite Assay Recalled by Microgenics Corp Due to Surveillance of reagent stability for specific lots of...

Date: July 23, 2013
Company: Microgenics Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Microgenics Corp directly.

Affected Products

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.

Quantity: 1473 units in distribution.

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 21 states: AL, AR, CA, CT, FL, GA, IL, KS, KY, LA, MD, MA, NJ, NY, NC, OH, TN, TX, VA, WA, DC

Affected (21 states)Not affected

About Microgenics Corp

Microgenics Corp has 2 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report