FDA-Device2022-04-27Class III
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.
Beckman Coulter, Inc.
Hazard
IRISpec CA failures for glucose.
Sold states
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.
Affected count
12,306 kits
Manufactured in
11800 Sw 147th Ave, Miami, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2022Don't want to check this manually?
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