FDA Medical Device Recalls (openFDA)
Express Diagnostics Int'l., Inc.: 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.
- Recall number
- Z-1033-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-11-21
- Posted
- 2015-01-30
- Terminated
- 2019-05-14
- Reason
- 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
- 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 Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.
- Quantity
- 5,050
- Distribution
- Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
- Lot, serial or model codes
- PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MGX
- Firm FEI
- 3014946040
- Firm city
- Blue Earth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28