Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3034-2020·Announced 2020-10-07

Ameditech Fastect II Drug Screen Dipstick Tests Recalled for Performance Failures

Ameditech is recalling Fastect II Drug Screen Dipstick Tests because they failed to consistently detect 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. The hazard involves inaccurate test results due to performance failures, which is a moderate risk without reported injuries or deaths.

Plain-English summary

Ameditech Inc is recalling 108,000 units of Fastect II Drug Screen Dipstick Tests. The recall covers various single and multi-drug detection models, including tests for substances such as THC, COC, OPI, BZO, BUP, MTD, TCA, OXY, MET, and AMP.

The recall was initiated because various immunoassay enzymes failed product performance. As a result, the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. The affected units include all lots within their expiry dates.

The products were distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. Users should stop using the affected products and contact Ameditech Inc for further instructions.

The recalled product

Product: Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect¿ II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20…
Manufacturer: Ameditech Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
performance-failure
Affected units: 108,000

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 · inaccurate results