Z-1033-2015Class II

DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and...

Name: Z-1033-2015 DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and...
Creator: Express Diagnostics Int'l., Inc.
Published: 2014-11-21
License: https://open.fda.gov/license/

Express Diagnostics Int'l., Inc. / initiated 2014-11-21 / Terminated / root cause: manufacturing process

FDA source

Express Diagnostics Int'l., Inc. began a recall of DrugCheck 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... on 2014-11-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1033-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Posted: 2015-01-30
Terminated: 2019-05-14
Recalling firm: Express Diagnostics Int'l., Inc.
Product: DrugCheck 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.
Product code: MGX Test System, For Drugs Of Abuse
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees 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 [email protected]. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.
Quantity in commerce: 5,050
Distribution: Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
Product codes and lots: PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1033-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1033-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-01-30

Product code MGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)