medical Class II Updated 2020-10-07

Ameditech Inc recalls MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/

Recalled Product

MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "

Hazard / Issue

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ALL Lots Within Expiry
View official government recall

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