FDA recall Z-2423-2020

Product

AIA-900 Analyzer, Part no. 022930, UDI 04560189283992

Reason for recall

The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.

Distribution

Domestic distribution nationwide. Foreign distribution to Chile, Costa Rica, Cayman Islands, Dominican Republic, Ecuador, Guatemala, Honduras, Peru, Republic of Panama, El Salvador, and Uruguay.

Key facts

Status

Terminated

Initiation date

2020-05-22

Report date

2020-07-01

Termination date

2024-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Grove City, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2423-2020