Medtox Diagnostics Recalls PROFILE-V MEDTOXScan Drugs of Abuse Test System
Medtox Diagnostics is recalling PROFILE-V MEDTOXScan Drugs of Abuse Test Systems due to preliminary screen positive results for cocaine that were not positive on confirmatory testing.
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. The hazard involves false positive results for cocaine, which is a significant diagnostic error but does not involve a direct physical injury or high-risk pathogen, fitting the Moderate severity criteria for labeling or performance errors without reported physical harm.
Plain-English summary
Medtox Diagnostics Inc is recalling the PROFILE-V MEDTOXScan Drugs of Abuse Test System. This product is used for the rapid, qualitative detection of drugs of abuse in human urine.
The recall was initiated following a review of validation information and customer complaints. These reviews indicated that the test system produced preliminary screen positive results for cocaine that were not positive on confirmatory testing.
The recall affects 221,625 units distributed nationwide in the United States and in Canada. Specific part numbers and lot numbers are listed in the official recall documentation. Users should stop using the affected test systems and contact Medtox Diagnostics for instructions on how to return the product.
The recalled product
- Product
- PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
- Manufacturer
- Medtox Diagnostics Inc
- Hazard
- Affected units
- 221,625
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 (20)
- Part No. 604018 - Lot No. 6821
- 6822
- 6823
- 6824
- 6825
- 6831
- 6832
- 6841
- 6851
- 6852
- 6853
- 6861
- 6862
- 6863
- 6864
- 6865
- 6866
- 6867
- 6868
- 6871
Distribution
Distributed nationwide across the United States.
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