Agency classClass IIOur severity:High FDA (Devices)·Z-3043-2020·Announced 2020-10-07

Ameditech Recalls QuickTox Drug Screen DipCards Due to Performance Failures

Ameditech is recalling QuickTox Drug Screen DipCards because immunoassay enzymes failed performance tests, meaning the products may not 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 medical device failing to perform as labeled, which poses a risk of harm through inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Ameditech Inc is recalling 170,425 units of QuickTox Drug Screen DipCards. The recall covers multiple product variants, including QT70, QT88, QT11, QT52, QT44, QT23, QT80F, QT52A, and QT20, across all lots within their expiry dates. These products are 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 product performance standards. As a result, the DipCards do not consistently detect all calibrator and secondary compounds at the levels stated in the product labeling. This performance failure may lead to inaccurate drug screening results.

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

The recalled product

Product: QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection…
Manufacturer: Ameditech Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
performance-failure
Affected units: 170,425

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