Recall Z-0565-2007 ยท GIF Diluent, Blood Cell
Abbott Laboratories
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
| Date | Mar 1, 2007 (initiated Dec 22, 2006) |
| Status | Terminated |
| Reason | Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems. |
| Root cause | Other |
| Action | Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters. |
| Quantity | 652 (20 L. each) cubitainers |
| Distribution | Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong. |
| FDA record | Open on fda.gov |