Recall Z-0474-06 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc
COULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R
| Date | Feb 4, 2006 (initiated Dec 15, 2005) |
| Status | Terminated |
| Reason | There is a risk of sample misidentification when processing samples in the Manual aspiration mode. |
| Root cause | Other |
| Action | A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail) |
| Quantity | 1715 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011342 | COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 Beckman Coulter, Inc., Jul 9, 2001 |