FDA recall Z-0984-2022

Product

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

Reason for recall

IRISpec CA failures for glucose.

Distribution

Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

Key facts

Status

Ongoing

Initiation date

2022-02-16

Report date

2022-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2022