Recall Z-1033-2015— Express Diagnostics Int'l., Inc.
Class II · Terminated
Class II FDA medical device recall by Express Diagnostics Int'l., Inc., initiated 2014-11-21, terminated 2019-05-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Express Diagnostics Int'l., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-21
- Terminated
- 2019-05-14
- Firm location
- Blue Earth, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.