Recall Z-0475-06 ยท GKJ Spinner, Slide, Automated
Beckman Coulter Inc
COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
| 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 | 1134 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962988 | COULTER GEN-S SYSTEM Coulter Corp., Oct 30, 1996 |