Recall Z-0527-06 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
| Date | Feb 16, 2006 (initiated Dec 16, 2005) |
| Status | Terminated |
| Reason | T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%. |
| Root cause | Other |
| Action | The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system. |
| Quantity | 871 units |
| Distribution | Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010953 | CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY Abbott Laboratories, Jun 6, 2001 |