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U.S. Department of Health and Human Services

Class 2 Device Recall DrugCheck

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  Class 2 Device Recall DrugCheck see related information
Date Initiated by Firm March 18, 2011
Date Posted May 27, 2011
Recall Status1 Terminated 3 on July 06, 2012
Recall Number Z-2387-2011
Recall Event ID 58652
510(K)Number K042975  k053175  k050186  k063015  
Product Classification Enzyme immunoassay, opiates - Product Code DJG
Product 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.
Code Information Product Code Lot Number   70801-4 4-801 112210 70801-4 4-801 102910 65500-4A 4A-500 110310  30705 705 112210 60702-6A AUS 6A-702 112910 60702-6A AUS 6A-702 113010 60600-A A600 110310 61205 205 110410 70701-4 4-701 102910 31012-6 6-012 110310 31003 003 102510
Recalling Firm/
Manufacturer		 Express Diagnostics Int'l., Inc.
1550 Industrial Dr
Blue Earth MN 56013-1100
For Additional Information Contact
507-526-3951
Manufacturer 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.
FDA Determined
Cause 2		 Incorrect or no expiration date
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.
Quantity in Commerce 6925 devices
Distribution Worldwide distribution: USA (nationwide) including states of: FL, IA, MD, OK, and WA; and countries including: AUSTRALIA and ITALY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DJG and Original Applicant = AMEDITECH, INC.
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