Ameditech Recalls Benzodiazepine Drug Abuse Tests Due to Reduced Reactivity
Ameditech is recalling EDI BZO Uncut Sheet-Card drug abuse tests because they have shown reduced reactivity. The affected units were distributed nationwide in the US and internationally to Australia.
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 inaccurate results (false negatives/positives) but does not involve direct physical injury or reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ameditech Inc is recalling EDI BZO Uncut Sheet-Card, Item No. 100170, which are one-step immunoassays for the qualitative detection of benzodiazepines in human urine. The recall is being conducted because the tests have shown reduced reactivity. These tests are intended for professional and point-of-care use to obtain visual, qualitative results.
A total of 70,364 units are affected by this recall. The products were distributed nationwide in the United States and internationally to Australia. The recall covers specific lot codes listed in the agency's documentation.
Consumers and healthcare professionals should stop using the affected drug abuse tests and contact Ameditech Inc for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- EDI BZO UNCUT SHEET-CARD, Item No. 100170 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 strips, including
- Manufacturer
- Ameditech Inc
- Affected units
- 70,364
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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