Ameditech Recalls ProScreen Drugs of Abuse Tests Due to Performance Failures
Ameditech is recalling ProScreen Drugs of Abuse Tests because immunoassay enzymes failed performance standards, causing inconsistent detection of compounds.
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 a risk of harm (inaccurate medical test results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ameditech Inc is recalling 51,075 units of ProScreen Drugs of Abuse Tests. The affected products include various test kits and cups designed to detect substances such as amphetamines, cocaine, methadone, opiates, and THC.
The recall was initiated because various immunoassay enzymes in the products failed to meet performance standards. As a result, the tests do not consistently detect all calibrator and secondary compounds at the levels stated in the product labeling. This defect may lead to inaccurate test results.
The recalled products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. All lots within the expiry date are affected. Users should stop using these products and contact Ameditech Inc for further instructions.
The recalled product
- Product
- ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET
- Manufacturer
- Ameditech Inc
- Affected units
- 51,075
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)
- ALL Lots Within Expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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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