DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE — Class II medical device recall Z-1033-2015
Terminated recall by Express Diagnostics Int'l., Inc., reported 2015-02-11, distributed in CA, MN, NY, SC. This recall has been initiated due to potential false positives results when using the test to screen for Keta
| Recall number | Z-1033-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Express Diagnostics Int'l., Inc., Blue Earth, MN, United States |
| Recall initiated | 2014-11-21 |
| Classified | 2015-01-30 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2019-05-14 |
| Distributed | CA, MN, NY, SC |
| Countries outside the US | CA, GB, GT, SE |
| Quantity | 5,050 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1033-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.