FDA recall Z-1420-2020

Product

AIA-360 Automated Immunoassay Analyzer, Product Code 019945

Reason for recall

A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.

Distribution

Distributed to AZ, NE, NJ, NY, and WA. Foreign distribution to Cayman Islands, Costa Rica, and Uruguay

Key facts

Status

Terminated

Initiation date

2020-01-10

Report date

2020-03-11

Termination date

2020-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1420-2020