Recall Z-0455-2008 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113
| Date | Mar 13, 2008 (initiated Oct 27, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, Mexico, Paraguay, Puerto Rico, Singapore, South Korea and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030513 | CELL-DYN 1800 SYSTEM Abbott Laboratories, May 12, 2003 |