DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenic

FDA device recall Z-2267-2013 · posted 2013-09-23 · Terminated

Recall details

Recalling firm

Microgenics Corp

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.

Action taken

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 with the controls at +/-25% of the cutoff, a possibility of reporting incorrect patient results is minimal to nonexistent. The use of appropriate controls addresses an risks of incorrect results. In addition to stopping use of the affected reagent, customers are asked to contact Thermo Fisher Scientific for replacement and to keep a copy of the recall letter for laboratory files. If the affected lots of reagent were forwarded to any other laboratories, they should be contacted immediately.. The enclosed acknowledgement form is to be completed and returned indicating that the letter was received, how much product, if any was on hand and destroyed. Questions and concerns may be addressed to Microgenics Technical Service at 1-800-232-3342 or 510-979-5417.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DIO

Quantity affected

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

Date initiated

2013-07-23

Date posted

2013-09-23

Date terminated

2013-12-02

Location

Fremont, CA

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