DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers

FDA device recall Z-2387-2011 · posted 2011-05-27 · Terminated

Recall details

Recalling firm

Express Diagnostics Int'l., Inc.

Reason for recall

Express Diagnostics Int'l, Inc. has initiated a medical device recall on various model numbers of DrugCheck devices, This recall was due to incorrect product expiration dating after findings from an FDA inspection. Use of expired product may not work properly, and may give incorrect screening results.

Action taken

The firm, Express Diagnostic Int'l, Inc., sent an "Urgent Recall of DrugCheck Product" letter dated April 19, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine the product; notify Express Diagnostic of the quantity even if no product is remaining; complete and return the DISTRIBUTOR/CUSTOMER RECALL CONFIRMATION FROM via fax to 1-507-526-2252 as soon as possible. In addition, if they have further distributed the product to identify their customers and notify them of the recall. Provided procedures to be followed for them to destroy the quarantined product. Express Diagnostics will replace the DrugCheck Drug Screen devices. If you have any questions, please contact the Quality Assurance Manager at 507-526-3951, ext. 117.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

DJG

Quantity affected

6925 devices

Distribution

Worldwide distribution: USA (nationwide) including states of: FL, IA, MD, OK, and WA; and countries including: AUSTRALIA and ITALY.

Date initiated

2011-03-18

Date posted

2011-05-27

Date terminated

2012-07-06

Location

Blue Earth, MN

Related 510(k) clearances