FDA Devices recall · Reported October 2, 2013
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
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…
Microgenics Corp recalled DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories.… - a moderate-severity action.
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories.… was recalled by Microgenics Corp in October 2, 2013. Reason: Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected dec…. Check the official notice for the remedy. Verify recall #Z-2267-2013 with the FDA Devices before acting.
The recall
Microgenics Corp issued this moderate-severity FDA Devices recall-Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected dec….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- October 2, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2267-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2267-2013 |
| Date reported | October 2, 2013 |
| Date initiated | July 23, 2013 |
| Recalling firm | Microgenics Corp |
| Firm location | Fremont, CA |
| Affected scope | 1473 units in distribution. |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2267-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026