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Terminated

DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Model numbers involved in the recall: 60670, 60700, 60713, 60717, 60870, 60923, 61012, 61019, 61023, 61024, 61040, 61042, 61057, 61102, 61105, 61203, 61204, 61206, 61208, 61301, 61303, 61401, 70603, 70809, 71032, 71043, 71055, 71065, 71202, 71204, 71205, 71401, 71402, 60718-3, 60720-6, 60925-A, 60927-3, 60930-A, 60980-3A, 61002-3, 61010-4, 61023-A, 61028-3A, 61039-4, 61040-A, 61055-A, 61056-3, 61057-6, 61100-3, 61102-3,61104-3,61105-5 CRL,61120-3,61202-4,61204-4,61204-A,61206-3A,61207-4,61302-3, 61303-A, 61401-A, 70660-3, 70716-3, 71045-A, 71055-6, 71102-3A, 71204-4, 71206-3A. In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

FDA Recall Z-3113-2011 · Posted 2011-08-31

Recalling FirmExpress Diagnostics Int'l., Inc.
Recall StatusTerminated
Product CodeJXN
Date Initiated2010-10-04
Date Terminated2012-07-06
Product Quantity196,750

Reason for Recall

Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use only", meaning they cannot be distributed or used for treatment or diagnostic purposed in the United States.

Firm Action

The firm, Express Diagnostics Int'l, Inc., sent a "RECALL NOTICE" letter dated October 4, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to notify their customers of the labeling change, and complete and return the DISTRIBUTOR/CUSTOMER CONFIRMATION FORM via fax to Express Diagnostics Int'l, Inc., at 1-507-526-2252. The letter also noted that "Further shipment of product containing BUP and/or PPX cannot continue until Express Diagnostics Int'l, Inc. receives the signed form." If you have any questions, call 507-526-3951.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide distribution:AZ, CA, CT, GA, MD, MA, MN, MO, NH, NJ, OR, SC, and WA.

Official Source

View FDA Recall →

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

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