Ameditech Recalls Alere iScreen Single Drug Detection Dip Cards
Ameditech is recalling Alere iScreen Single Drug Detection dip cards because they may fail to consistently detect certain compounds at labeled levels.
What this means for you
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Ameditech Inc is recalling 303,100 units of Alere iScreen Single Drug Detection dip cards. The affected products include single dip cards designed to detect various substances, including buprenorphine, barbiturates, oxycodone, benzodiazepines, methamphetamine, amphetamine, ecstasy, methadone, morphine, marijuana, tricyclic antidepressants, and phencyclidine. The recall covers all lots within the expiry date.
The recall was initiated because various immunoassay enzymes in the products failed to meet performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This performance failure may lead to inaccurate test results.
The affected products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. Users of these products should stop using them and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-D
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 303,100
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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