Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbe
FDA device recall Z-0246-2007 · posted 2006-12-05 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRY
- Quantity affected
- 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, M
- Date initiated
- 2006-09-18
- Date posted
- 2006-12-05
- Date terminated
- 2007-11-28
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN CALIBRATOR (K902892) | Unipath , Ltd. | 1990-09-10 |