Device product
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Z-0777-2023
Product summary
- Event
- Event 91175
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3657 units
- Official record key
device-enforcement:Z-0777-2023
Official wording
Reason: Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
Code information: UDI/DI 10837461002611, Lot 565-21: 11-30-2022
Distribution pattern: US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Derived failure modes
-
Unknown
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212