Ameditech CLIA RDTC 12-Panel Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling 10,320 CLIA RDTC 12-Panel Cup kits nationwide 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 indicates the product is not likely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard like injury or death.
Plain-English summary
Ameditech Inc is recalling 10,320 units of the CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5. The affected products were distributed nationwide. The recall covers specific lot codes: 142709, 142840, 143008, 143571, 143665, 144217, 152234, and 152379.
The recall was initiated because the drugs of abuse tests have shown reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. The specific compounds affected are Clonazepam and Chlordiazepoxide. This issue may impact the accuracy of test results for these specific substances.
Users of these kits should check their inventory for the listed lot codes. If the products match the recalled items, they should stop using them and contact Ameditech Inc for further instructions on return or replacement.
The recalled product
- Product
- CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5
- Manufacturer
- Ameditech Inc
- Affected units
- 10,320
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)
- 142709 142840 143008 143571 143665 144217 152234 152379
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