DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT
FDA device recall Z-1033-2015 · posted 2015-01-30 · Terminated
Recall details
- Recalling firm
- Express Diagnostics Int'l., Inc.
- 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.
- Action taken
- Consignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail Quality@drugcheck.com. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MGX
- Quantity affected
- 5,050
- Distribution
- Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.
- Date initiated
- 2014-11-21
- Date posted
- 2015-01-30
- Date terminated
- 2019-05-14
- Location
- Blue Earth, MN
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