Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3035-2020·Announced 2020-10-07

Ameditech Recalls One Step + DOA Cup Due to Performance Failures

Ameditech is recalling 31,800 units of the Henry Schein One Step + DOA Cup because the immunoassay enzymes failed performance tests, resulting in inconsistent detection of compounds.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The issue is a performance failure leading to inconsistent detection rather than a direct physical hazard like injury or death.

Plain-English summary

Ameditech Inc is recalling 31,800 units of the Henry Schein One Step + DOA Cup (AMT Item Number 570-1066). The recall covers all lots within their expiry dates. The product is a 14-panel drug of abuse cup used for testing various substances.

The recall was initiated because various immunoassay enzymes in the product failed performance requirements. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. This means the test results may not be reliable.

The affected units 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: Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",
Manufacturer: Ameditech Inc
Category: Medical Device — Diagnostic Test
Hazard: mis-labeling
performance-failure
Affected units: 31,800

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 →

Same manufacturer · Ameditech Inc

See all →

Moderate
Ameditech Noble 1 Step+ Cup Recalled for Inconsistent Performance
FDA (Devices) · 2020-10-07
Moderate
Ameditech Recalls First Check 14 Panel Drug Cups Due to Performance Failures
FDA (Devices) · 2020-10-07
High
Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures
FDA (Devices) · 2020-10-07
Moderate
Ameditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures
FDA (Devices) · 2020-10-07
High
Ameditech MicroTox Immunoassay Enzymes Recalled for Performance Failures
FDA (Devices) · 2020-10-07

Same hazard · mis labeling