Medical device recalls Moderate risk

Express Diagnostics Int'l., Inc. recalls DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C IN…

Recall date
November 21, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1033-2015
FDA classification
Class II
Brand / firm
Express Diagnostics Int'l., Inc.
Sold / distributed
Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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