Ameditech Recalls Premier Clia Waived 12 Panel Tilt Cup Drug Tests
Ameditech is recalling Premier Clia Waived 12 Panel Tilt Cup drug tests because they have shown reduced reactivity.
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 II. The hazard is reduced reactivity, which is a performance defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ameditech is recalling the Premier Clia Waived 12 Panel Tilt Cup, Item No. C12APC. These are one-step immunoassays used for the qualitative detection of multiple drugs and drug metabolites in human urine. The tests are intended for professional and point-of-care use.
The recall was initiated because the drug abuse tests have shown reduced reactivity. The source text does not specify the exact cause of the reduced reactivity or the specific drugs affected, though the product description notes the configuration includes Benzodiazepine (BZO) strips.
The recall involves 384 units. Distribution was worldwide, including the United States (nationwide) and Australia. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units.
The recalled product
- Product
- Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC 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 Abuse Tests consist of a combination of drug st
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 384
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)
- 141748
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.
See all 20 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