DrugCheck, Distributed by Express Diagnostics Int'l Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following cup Mod

FDA device recall Z-3113-2011 · posted 2011-08-31 · Terminated

Recall details

Recalling firm

Express Diagnostics Int'l., Inc.

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.

Action taken

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

Status

Terminated

Product code

JXN

Quantity affected

196,750

Distribution

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

Date initiated

2010-10-04

Date posted

2011-08-31

Date terminated

2012-07-06

Location

Blue Earth, MN