Ameditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity
Ameditech is recalling 11 Panel Dip Cards (OPI 2000 and OPI 300) because they have shown reduced reactivity. The recall covers 150 units distributed in the US and 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 high-risk pathogens, fitting the 'High' severity criteria for risk-of-harm products where injury has not been reported.
Plain-English summary
Ameditech Inc is recalling 150 units of 11 Panel Dip Cards, specifically the OPI 2000 (Item No. 11125AA2K) and OPI 300 w/Adult (Item No. 11125AA) models. These products are one-step immunoassays intended for the qualitative detection of multiple drugs and drug metabolites in human urine, including Benzodiazepine (BZO). They are designed for professional and point-of-care use.
The recall was initiated because the drug abuse tests have shown reduced reactivity. The affected units were distributed nationwide in the United States and internationally to Australia. The specific lot codes associated with this recall are 142898, 151145, and 142899.
Users of these products should stop using the affected dip cards and contact Ameditech Inc for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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
- Manufacturer
- Ameditech Inc
- Affected units
- 150
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)
- 142898 151145 142899
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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