RecallWatchUSA

Home / Recalls / Medical Devices

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

Recalled April 27, 2022 · FDA recall Z-0984-2022 · Beckman Coulter

Hazard
IRISpec CA failures for glucose. · FDA Class III
Units
12,306 kits
Sold at
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.

Description

IRISpec CA failures for glucose.

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.
Manufacturer(s)
Beckman Coulter, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov