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Terminated

DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers : 70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR, Lot 4-801 102910, Exp APR 2012, & Lot 4-801 112210, Exp MAY 2012, Export Only); 65500-4A (AMP-COC--OP1-TCH-MET-ALC-pH,SG-NI,CR, Lot 4A-500 110310, Exp MAY 2012, For forensic use only); 30705 ( DIP DRUG TEST, AMP500/COC/MDMA/MET500/MTD/OP1300/TCH, Lot 705 112210, Exp MAY 2012); 60702-6A AUS (AMP300-COC300-OP1300-OP12000-MET300-TCH50-BZ0200-ALC-pH,SG,OX-NI,CR-GL, Lot 6A-702 113010 & 6A-702 112910, Exp MAY 2012, Export Only); 60600-A (AMP-COC--OP1-TCH-MET-BZO-ALC, Lot A600 110310, Exp MAY 2012, For forensic use only); 61205 (AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC, Lot 205 110410, Exp MAY 2012); 70701-4 (NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-pH,SG-NI,CR, Lot 4-701 102910, Exp APR 2012, Export Only); 31012-6 (DIP DRUG TEST, AMP/BAR/BZO/COC/MDMA/MTD/OPI/OXY/ PCP/THC/pH SG, OX/NI, CR, GL, Lot 6-012 110310, Exp MAY 2012); 31003 (AMP/COC/OP10300/THC/MET/BZO/BAR/PCP/MTD/TCA/MET, Lot 003 102510, Exp APR 2012); Intended use: The DrugCheck Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

FDA Recall Z-2387-2011 · Posted 2011-05-27

Recalling FirmExpress Diagnostics Int'l., Inc.
Recall StatusTerminated
Product CodeDJG
Date Initiated2011-03-18
Date Terminated2012-07-06
Product Quantity6925 devices

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.

Firm Action

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

Distribution Pattern

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

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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