Express Diagnostics Int'l., Inc.: Medical Device Recall in 2015 - (Recall #: Z-1033-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 21, 2014

Date Posted: February 11, 2015

Recall Number: Z-1033-2015

Event ID: 70008

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.

Status: Terminated

Product Quantity: 5,050

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated