Agency classClass IIOur severity:High FDA (Devices)·Z-3036-2020·Announced 2020-10-07

Ameditech Recalls ImmuTest Drugs of Abuse Cups for Performance Failures

Ameditech is recalling ImmuTest Drugs of Abuse Cups because they failed to consistently detect all 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm due to inconsistent detection of compounds, which could lead to incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ameditech Inc is recalling 27,375 units of ImmuTest Drugs of Abuse Cups. The affected products include specific item numbers such as IMCA-5AB-W, IMC-8BBCE, and IMCA-8CM5. These products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain.

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 issue affects all lots within their expiry dates.

Users of these products should stop using them and contact Ameditech Inc for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection…
Manufacturer: Ameditech Inc
Category: Medical Device — Diagnostic Test
Hazard: mis-labeling
performance-failure
Affected units: 27,375

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

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Same hazard · mis labeling