Class 2 Device Recall DRI Cocaine Metabolite Assay, Multigent Cocaine Assay

• Date Initiated by Firm: July 23, 2013
• Date Posted: September 23, 2013
• Recall Status: Terminated on December 02, 2013
• Recall Number: Z-2267-2013
• Recall Event ID: 65883
• 510(K)Number: K960187
• Product Classification: Enzyme immunoassay, cocaine and cocaine metabolites - Product Code DIO
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Microgenics Corp; 46360 Fremont Blvd; Fremont CA 94538-6406
• For Additional Information Contact: Laurie Wong; 510-979-5145
• Manufacturer 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.
• FDA Determined 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 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.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DIO and Original Applicant = DIAGNOSTIC REAGENTS, INC.