Ameditech ProScreen 12 Panel Cup Recall for Reduced Benzodiazepine Reactivity
Ameditech is recalling ProScreen 12 Panel Cups because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is typically a score of 1 or 2. It is scored as 2 because it involves a diagnostic performance issue (reduced reactivity) rather than a cosmetic or documentation-only defect.
Plain-English summary
Ameditech Inc is recalling 1,200 kits of the ProScreen 12 Panel Cup w/Adult. (Item No. PSCupA-12M). The affected products were distributed nationwide.
The recall is due to reduced reactivity for up to two of the nineteen Benzodiazepine (BZO) compounds listed in the product insert. Specifically, the tests may show reduced reactivity for Clonazepam and Chlordiazepoxide.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or replacement of these kits.
The recalled product
- Product
- ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Affected units
- 1,200
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)
- 142570 144104
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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateAmeditech Recalls ProScreen Drug Panel Tests Due to Reduced Reactivity
FDA (Devices) · 2015-11-25
- ModerateAmeditech Recalls 6 Panel Drug Detection Cups Due to Reduced Reactivity
FDA (Devices) · 2015-11-25
- ModerateAmeditech Recalls 1 Step 12 Panel Cup Drug Tests
FDA (Devices) · 2015-11-25
- ModerateAmeditech Recalls Premier Clia Waived 12 Panel Tilt Cup Drug Tests
FDA (Devices) · 2015-11-25
- ModerateAmeditech Recalls iCup Drug Screen Cups Due to Reduced Reactivity
FDA (Devices) · 2015-11-25
- ModerateAmeditech Recalls 11 Panel Drug Abuse Tests Due to Reduced Reactivity
FDA (Devices) · 2015-11-25