Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3041-2020·Announced 2020-10-07

Ameditech Recalls Oratect III Oral Fluid Drug Screen Devices

Ameditech Inc is voluntarily recalling 1,325 units of Oratect III Oral Fluid Drug Screen Devices due to a Class II safety concern.

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 temporary or medically reversible adverse health consequence. As no specific injuries, illnesses, or fatalities are reported in the source text, and the recall is voluntary, it aligns with the Moderate severity criteria for precautionary or low-risk contamination/labeling issues.

Plain-English summary

Ameditech Inc has voluntarily initiated a Class II recall of 1,325 units of the Oratect III Oral Fluid Drug Screen Device. The recall was initiated on August 18, 2020, and the devices are identified by AMT Item Number HM12-CE. The specific reason for the recall is not detailed in the provided source text.

The affected devices were distributed nationwide in the United States as well as in Australia, France, Germany, New Zealand, Singapore, and Spain. The recall covers all lots within their expiry dates. The recall status is currently listed as Terminated, with a termination date of September 30, 2024.

Consumers and healthcare providers who possess these devices should stop using them and contact Ameditech Inc for further instructions on return or disposal. The recall was initiated by the firm and notified via letter.

The recalled product

Product: Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "
Manufacturer: Ameditech Inc
Category: Medical Device — Diagnostic Test
Hazard: mis-labeling
quality-control
Affected units: 1,325

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 →

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Same hazard · mis labeling