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U.S. Department of Health and Human Services

Class 2 Device Recall DrugCheck Drugs of Abuse Ketamine Dip Test

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 Class 2 Device Recall DrugCheck Drugs of Abuse Ketamine Dip Testsee related information
Date Initiated by FirmNovember 21, 2014
Date PostedJanuary 30, 2015
Recall Status1 Terminated 3 on May 14, 2019
Recall NumberZ-1033-2015
Recall Event ID 70008
Product Classification Test system, for drugs of abuse - Product Code MGX
ProductDrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
Code Information PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.  
Recalling Firm/
Manufacturer		 Express Diagnostics Int'l., Inc.
1550 Industrial Dr
Blue Earth MN 56013-1100
For Additional Information ContactJackie Gale
507-526-3951
Manufacturer Reason
for Recall		This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionConsignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.
Quantity in Commerce5,050
DistributionWorldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
Total Product Life CycleTPLC 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.
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