FDA-Device2015-02-11Class II

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.

Express Diagnostics Int'l., Inc.
Hazard

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.

Sold states
Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
Affected count
5,050
Manufactured in
1550 Industrial Dr, N/A, Blue Earth, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1033-2015

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