Recall Z-0648-03 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
| Date | Mar 13, 2003 (initiated Oct 16, 2002) |
| Status | Terminated |
| Reason | Product elicits fluorescent signal interference due to contamination. |
| Root cause | Other |
| Action | On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices. |
| Quantity | 1383 units |
| Distribution | Nationwide and Argentina, Canada and Puerto Rico. |
| 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 |
| K961439 | ABBOTT CELL-DYN 4000 SYSTEM Abbott Diagnostics, Oct 18, 1996 |
| K971152 | ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) Abbott Laboratories, Aug 12, 1997 |
| K981342 | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY Abbott Laboratories, Jun 29, 1998 |