FDA Device recall Z-1033-2015
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 provid…
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of 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 provid… by Express Diagnostics Int L, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1033-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-21 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Express Diagnostics Int L |
| Distribution | CA, MN, NY, SC |
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.
Identifiers
| code_info | PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1033-2015%22
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