Home / Recalls / Express Diagnostics Int'l., Inc. / Z-1033-2015

Z-1033-2015 Class II Terminated

Recalled by Express Diagnostics Int'l., Inc. — Blue Earth, MN

Recall Details

Product Type: Devices
Report Date: February 11, 2015
Initiation Date: November 21, 2014
Termination Date: May 14, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,050

Product Description

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.

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.

Distribution Pattern

Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.

Code Information

PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.