Beckman Coulter, Inc. Recall 89655
Description: 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. Recall 89655 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0984-2022 |
| Event ID | 89655 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Brazil, Canada, Curacao, Guatemala, Mexico, Philippines, Singapore, and Taiwan. |
| Quantity | 12,306 kits |
| Recall Reason | IRISpec CA failures for glucose. |
| Device Classification | 20220427 |
| Device Code Info | Lot #583-21 and higher, UDI 10837461002611. |
| Center Classification Date | 20220421 |
| Recall Initiation Date | 20220216 |
| Recalling Firm | Beckman Coulter, Inc. |
| Initial Notification | Letter |
| Similar To |