Recall Z-2267-2013 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Microgenics Corp
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
| Date | Sep 23, 2013 (initiated Jul 23, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Thermo Fisher Scientific sent an Urgent Medical Device Recall letters dated July 23, 2013, except Abbott labs who was mailed a letter on August 2, 2013. Abbott had previously been notified by telephone of the recall.The letter identified the product the problem and the action needed to be taken by the customer. Customers advised users on reagent stability issue with specific lots and the fact that it indicated a faster than expected degradation of the reagent. Microgenics asked that all use of the affected lots be stopped. Customers were informed that since each patient run is monitored wit |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960187 | COCAINE METABOLITE EIA TEST Diagnostic Reagents, Inc., Apr 2, 1996 |