Ameditech Recalls Alere iScreen Single Drug Detection Dip Cards
Ameditech is recalling Alere iScreen Single Drug Detection dip cards because they may fail to consistently detect certain compounds at labeled levels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Ameditech Inc is recalling 303,100 units of Alere iScreen Single Drug Detection dip cards. The affected products include single dip cards designed to detect various substances, including buprenorphine, barbiturates, oxycodone, benzodiazepines, methamphetamine, amphetamine, ecstasy, methadone, morphine, marijuana, tricyclic antidepressants, and phencyclidine. The recall covers all lots within the expiry date.
The recall was initiated because various immunoassay enzymes in the products failed to meet performance standards. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This performance failure may lead to inaccurate test results.
The affected products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. Users of these products should stop using them and contact Ameditech Inc for further instructions or a replacement.
The recalled product
- Product
- Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1…
- Manufacturer
- Ameditech Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 303,100
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)
- ALL Lots Within Expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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 23 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 · inaccurate results
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- HighAmeditech Recalls 11 Panel Dip Cards Due to Reduced Reactivity
FDA (Devices) · 2015-11-25
- LowAlere iScreen Dx Urine Drug Screen Card Recalled for Labeling Error
FDA (Devices) · 2017-09-06
- ModerateAmeditech Recalls QuickTox 5 Panel Drug Screen DipCard
FDA (Devices) · 2019-12-25
- ModerateAmeditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error
FDA (Devices) · 2014-10-22
- LowAmeditech Recalls Alere iScreen Dx Urine Drug Screen Cards for Labeling Error
FDA (Devices) · 2018-05-09
- ModerateAmeditech Recalls ArcPoint Labs 5 Panel Dip Drug Screen Due to Labeling Error
FDA (Devices) · 2014-10-22