Ameditech Recalls DrugCheck Waived 12 Panel Cup Tests
Ameditech is recalling DrugCheck Waived 12 Panel Cup tests because they have shown reduced reactivity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves reduced reactivity in diagnostic tests, which poses a risk of harm through inaccurate results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ameditech Inc is recalling DrugCheck Waived 12 Panel Cup w/Adult tests, Item No. DCC-81205-5. These are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine, intended for professional and point-of-care use.
The recall was initiated because the tests have shown reduced reactivity. The affected units are associated with codes 144216, 150546, and 150746.
The recall involves 1,104 units that were distributed nationwide in the United States and internationally to Australia. Consumers and healthcare professionals should stop using the affected tests and contact Ameditech Inc for further instructions.
The recalled product
- Product
- DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 1,104
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 (1)
- 144216 150546 150746
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Ameditech Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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