FDA recall Z-3037-2020

Product

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

Reason for recall

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.

Distribution

US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

Key facts

Status

Terminated

Initiation date

2020-08-18

Report date

2020-10-07

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3037-2020