Z-1033-2015 Class II Terminated
FDA device recall Z-1033-2015 was initiated by Express Diagnostics Int'l., Inc. on November 21, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 14, 2019). Affected quantity: 5,050.
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.