Ameditech ProScreen 10 Panel Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 10 Panel Cups because they may show reduced reactivity for two specific benzodiazepine compounds.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classification is Class III, which by definition indicates the product is unlikely to cause adverse health consequences. The issue is a performance defect (reduced reactivity) rather than a direct physical hazard.
Plain-English summary
Ameditech Inc is recalling 3,411 kits of the ProScreen 10 Panel Cup (Item No. PSCup-10M). The affected products were distributed nationwide. The recall involves specific lot codes listed in the agency record.
The recall is due to reduced reactivity for up to two of the nineteen benzodiazepine compounds for which specificity information is provided in the product insert. The specific compounds with potential reduced reactivity are Clonazepam and Chlordiazepoxide. This issue may affect the accuracy of drug-of-abuse test results for these specific substances.
Consumers and healthcare providers should stop using the affected kits and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- ProScreen 10 Panel Cup, Item No. PSCup-10M
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 3,411
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 · test inaccuracy
See all →- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- ModerateOrtho Clinical Diagnostics Total Bili-Alkp XT Reagent Recall
FDA (Devices) · 2025-06-04
- ModerateORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide
FDA (Devices) · 2025-06-04
- HighSiemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy
FDA (Devices) · 2024-11-27
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15