Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/M
FDA device recall Z-0455-2008 · posted 2008-03-13 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.
- Action taken
- A Product Correction letter was sent to all customers with a reply form on October 27, 2006. Product information letters are being packed with the instrument's accessory kit and with calibrators and quality control products used with the CELL-DYN 1800 System. Correction letters with reply forms have been resent to nonresponding customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 4,224 Systems
- Distribution
- Worldwide Distribution, USA and countries of Argentina, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Dominican Republic, El Salvador, Germany, Guatemala, Honduras, Hong Kong, China, Japan, Me
- Date initiated
- 2006-10-27
- Date posted
- 2008-03-13
- Date terminated
- 2011-01-06
- 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 1800 SYSTEM (K030513) | Abbott Laboratories | 2003-05-12 |