Z-0777-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2023
- Initiation Date
- November 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3657 units
Product Description
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Reason for Recall
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
Distribution Pattern
US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Code Information
UDI/DI 10837461002611, Lot 565-21: 11-30-2022