Recall Z-0246-2007 ยท KRY Calibrator For Platelet Counting
Abbott Laboratories
Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01
| Date | Dec 5, 2006 (initiated Sep 18, 2006) |
| Status | Terminated |
| Reason | Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results. |
| Root cause | Other |
| Action | The firm notified its consignees via customer letter sent on 09/18/2006, with information regarding the recall, requesting reply via a form included in the letter. |
| Quantity | 4708 units |
| Distribution | Worldwide, including USA, Costa Rica, Columbia, Ecuador, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, El Salvador, Germany, Japan, Philippines, Singapore, Hong Kong/China, Taiwan, Thailand, Malaysia, South Korea, Australia, New Zealand, Honduras, Nicaragua, Haiti, Bermuda, Virgin Islands, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902892 | CELL-DYN CALIBRATOR Unipath , Ltd., Sep 10, 1990 |