FDA Device recall Z-2267-2013
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 4636…
- FDA Device
- Class II
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class II recall of DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 4636… by Microgenics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2267-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-23 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microgenics |
| Distribution | AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, NC, NJ, NY, OH, TN, TX, VA, WA |
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.
Identifiers
| code_info | Part no. 0055, lot number 60053405, Exp 2/29/2016; Part No. 0056, lot number 60053396, Exp 2/29/2016; Part No. 100145…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2267-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.