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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