Ameditech Benzodiazepine Test Kits Recalled for Reduced Reactivity
Ameditech Inc is recalling 31,472 Benzodiazepine Strip Dip Card kits because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
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 III, which the rubric indicates is typically a score of 1 or 2. The hazard involves reduced reactivity (potential false negatives) rather than a direct physical injury or acute health threat, fitting the Moderate category for low-risk performance issues.
Plain-English summary
Ameditech Inc is recalling 31,472 kits of the BZO Strip Dip Card (300ng/ml), Item No. 100170. These products were distributed nationwide.
The recall was initiated because the drugs of abuse tests have shown reduced reactivity for up to two of the nineteen Benzodiazepine compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide.
Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for further instructions. The affected lot codes are: 141233, 141669, 141790, 141820, 141958, 142082, 142531, 142532, 142835, 143020, 143471, 143553, 152021, 152432, 152546, 153094, 153538, and 152104.
The recalled product
- Product
- BZO Strip Dip Card (300ng/ml)*, Item No. 100170
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 31,472
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 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.
See all 59 products in this recall →Related recalls
Same manufacturer · Ameditech Inc
See all →- ModerateAmeditech Noble 1 Step+ Cup Recalled for Inconsistent Performance
FDA (Devices) · 2020-10-07
- ModerateAmeditech iCup Dx14 Drug Screen Cup Recalled for Performance Failures
FDA (Devices) · 2020-10-07
- HighAmeditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAmeditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures
FDA (Devices) · 2020-10-07
- ModerateAmeditech Recalls One Step + DOA Cup Due to Performance Failures
FDA (Devices) · 2020-10-07
Same hazard · reduced reactivity
See all →- ModerateSerology ToRCH positive control specimen recalled for decreased HSV reactivity
FDA (Devices) · 2024-01-10
- LowAmeditech DrugSmart Dip Benzodiazepine Test Recall for Reduced Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech ProScreen 5 Panel Dip Card Recalled for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30
- ModerateAmeditech ProScreen 12 Drug Cup Recall for Reduced Benzodiazepine Reactivity
FDA (Devices) · 2015-12-30