FDA-Device2020-10-07Class II
MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
Hazard
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.
Sold states
US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Affected count
23,000 units
Manufactured in
9940 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3037-2020Don't want to check this manually?
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