Agency classClass IIOur severity:High FDA (Devices)·Z-3037-2020·Announced 2020-10-07

Ameditech MicroScreen Immunoassay Recalled for Inconsistent Detection Performance

Ameditech Inc is recalling 23,000 MicroScreen immunoassay units 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 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 23,000 units of MicroScreen immunoassay products, including specific configurations such as AMP300, BZO200, and THC50. The recall covers all lots within their expiration dates. 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 performance failure may lead to inaccurate test results.

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

The recalled product

Product: MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
Manufacturer: Ameditech Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-diagnosis
performance-failure
Affected units: 23,000

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 →

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Same hazard · inaccurate diagnosis