Branan Medical ToxCup Drug Screen Cups Recalled for Labeling Errors
Branan Medical is recalling ToxCup Drug Screen Cups because the lid labels may contain incorrect result interpretation graphics.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is limited to labeling errors regarding result interpretation, which fits the criteria for a moderate severity recall involving minor labeling issues.
Plain-English summary
Branan Medical Corporation is recalling approximately 9,800 units of ToxCup Drug Screen Cups. The affected catalogue numbers are HT15, HT15A, PT11, PT11A, PT15A, and PT23A. These devices are used for in vitro diagnostic screening of drugs and drug metabolites in human urine.
The recall was initiated because the ToxCup lid labels may be marked with incorrect result interpretation graphics. This labeling error could potentially lead to misinterpretation of the test results.
The affected products were distributed nationwide in the United States and in Canada. The specific lot numbers involved are O0056, O0067, N0854, O0103, O0099, O0100, O0057, O0059, O0060, and O0079. Users should check their inventory for these specific lot numbers and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.
- Manufacturer
- Branan Medical Corporation
- Hazard
- Affected units
- 9,800
Distribution
Distributed nationwide across the United States.
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