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Terminated

Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and Dip product models involved in the recall: 40900 40901 30500-A 30575 -A 30603-A 30671-A 30800-A 30802-3A 30900-A 30950-A 31102-A 40901C 60410-3A 60500-A 60505-A 60524-A 60526-A 60535-A 60600-A 60602-4A 60630-A 60635-4A 60640-4A 60705-4A 60709-A 60800-6A 60800-A 60801-A 60820-A 60903-A 60910-A 60921-A 60925-A 60930-A 61020-A 61023-A 61026-4A 61028-3A 61030-3A 61044-6A 61052-4A 61100-A 61204-A 61206-4A 61206-6A 61303-A 61401-A 61404-A 65500-4A 70410-4A 70500-3A 70500-A 70550-A 70602-3A 70604-6A 70630-3A 70640-4A 70808-6A 70910-A In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

FDA Recall Z-3104-2011 · Posted 2011-08-31

Recalling FirmExpress Diagnostics Int'l., Inc.
Recall StatusTerminated
Product CodeDIC
Date Initiated2010-11-01
Date Terminated2012-07-06
Product Quantity56,650

Reason for Recall

Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product was not 510 K cleared for in vitro diagnostic use and could not be labeled as such in the US.

Firm Action

Express Diagnostics Intl., Inc. sent an Updated Recall Notice dated November 1, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have open orders of the affected product to contact customer service about their order. Customers were asked to complete and fax the form on page 3 of the document to 507-526-2252. Further shipment of products could not continue until Express Diagnostics received the signed form. For questions regarding this recall call 507-526-3951.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution including AZ, CA,K CT, FL, GA, IL, IA, LA, MD, MA, MN, MS, MO,K MT, NE, NJ, NY, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150Ameditech, Inc. · 2006-12-20K053175AMEDITECH DRUGSMARTCUPAmeditech, Inc. · 2005-12-08K050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIAmeditech, Inc. · 2005-03-04K042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIAmeditech, Inc. · 2004-12-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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