DRI Cocaine Metabolite Assay — Class II medical device recall Z-2267-2013
Terminated recall by Microgenics Corp, reported 2013-10-02, distributed in AL, AR, CA, CT, DC, FL, GA, IL…. Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decre
| Recall number | Z-2267-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corp, Fremont, CA, United States |
| Recall initiated | 2013-07-23 |
| Classified | 2013-09-23 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2013-12-02 |
| Distributed | AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, NC, NJ, NY, OH, TN, TX, VA, WA |
| Quantity | 1,473 units |
| Reason classes | specification failure |
| Lot numbers | 24215M500, 60053396, 60053405, 60112588 |
| Model numbers | 0055, 0056, 10014593, L40-20 |
| Expiration dates | 2014-08-13, 2016-02-29 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2267-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.