FDA recall Z-0460-2022

Product

Alinity m System, Part No. 08N53-002

Reason for recall

There is a potential for abnormal (non-sigmoidal) amplification curves.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.

Key facts

Status

Ongoing

Initiation date

2021-12-06

Report date

2022-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Des Plaines, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0460-2022