FDA recall Z-0463-2022

Product

Alinity m System, Part No. 08N53-002

Reason for recall

There is an issue with the installation of updated camera firmware on the system.

Distribution

Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam

Key facts

Status

Terminated

Initiation date

2021-12-06

Report date

2022-01-12

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2022