Ameditech MicroTox Immunoassay Enzymes Recalled for Performance Failures
Ameditech Inc is recalling MicroTox immunoassay enzymes because they failed to consistently detect compounds at labeled levels.
What this means for you
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 risk of harm (inaccurate diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ameditech Inc is recalling MicroTox immunoassay enzymes, specifically item MTPA-6MBAU. The affected products are described as MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G. The recall covers 12, 100 units distributed nationwide in the US and in Australia, France, Germany, New Zealand, Singapore, and Spain. All lots within expiry are affected.
The recall was initiated because various immunoassay enzymes failed product performance tests. 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. The recall is classified as Class II by the FDA.
The recalled product
- Product
- MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."
- Manufacturer
- Ameditech Inc
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.
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