Device 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.
Z-0984-2022
Product summary
- Event
- Event 89655
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 12,306 kits
- Official record key
device-enforcement:Z-0984-2022
Official wording
Reason: IRISpec CA failures for glucose.
Code information: Lot #583-21 and higher, UDI 10837461002611.
Distribution pattern: Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan.
Derived failure modes
-
Unknown
IRISpec CA failures for glucose.