Agency classClass IIOur severity:High FDA (Devices)·Z-3030-2020·Announced 2020-10-07

Ameditech Recalls Alere iScreen Multi Drug Detection Tests

Ameditech is recalling Alere iScreen Multi Drug Detection tests because they may fail 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, and the hazard involves a risk of harm (inaccurate medical test results) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Ameditech Inc is recalling Alere iScreen Multi Drug Detection dip tests. The recall involves 67,300 units distributed nationwide in the United States and in Australia, France, Germany, New Zealand, Singapore, and Spain. The affected products include various configurations of the Alere iScreen Dx Multi-Drugs of Abuse Dip Test, such as 5-drug, 10-drug, and 12-drug detection panels.

The recall was initiated because various immunoassay enzymes failed product 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 could lead to inaccurate drug detection results.

Users of these products should stop using the recalled tests and contact Ameditech Inc for further instructions or a replacement. The recall covers all lots within their expiry dates.

The recalled product

Product: Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx…
Manufacturer: Ameditech Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
Affected units: 67,300

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