Express Diagnostics Recalls DrugCheck Ketamine Dip Tests for False Positives
Express Diagnostics is recalling DrugCheck Ketamine Dip Tests because they may produce false positive results, leading to incorrect screening outcomes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect screening results (false positives) without reports of physical injury or death, fitting the criteria for a moderate severity issue involving diagnostic accuracy.
Plain-English summary
Express Diagnostics Int'l., Inc. is recalling 5,050 units of DrugCheck Ketamine Dip Tests. The affected products include specific model numbers such as 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, and various 30108C variants. The recall was initiated because the tests may produce false positive results when used to screen for Ketamine.
The distribution of these products was worldwide, including the United States (specifically California, New York, Minnesota, and South Carolina), Sweden, Canada, the United Kingdom, and Guatemala. The recall is classified as Class II by the FDA.
Consumers and healthcare providers should stop using the affected DrugCheck Ketamine Dip Tests immediately. Since the assay provides only a preliminary analytical test result, incorrect screening results could lead to misinterpretation of patient status. Users should contact the manufacturer for further instructions on returns or replacements.
The recalled product
- 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.
- Manufacturer
- Express Diagnostics Int'l., Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 5,050
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- PC 09077
- PC03227
- PC03055
- PC09293
- PC11115
- PC08126
- PC06276
- PC07085
- PC06305
- and PC08017.
Distribution
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