Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and

FDA device recall Z-3104-2011 · posted 2011-08-31 · Terminated

Recall details

Recalling firm

Express Diagnostics Int'l., Inc.

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.

Action taken

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

Status

Terminated

Product code

DIC

Quantity affected

56,650

Distribution

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.

Date initiated

2010-11-01

Date posted

2011-08-31

Date terminated

2012-07-06

Location

Blue Earth, MN

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