Recall Z-0637-04 ยท GKL Counter, Cell, Automated (Particle Counter)
Beckman Coulter Inc
Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265
| Date | Jul 20, 2004 (initiated Feb 13, 2004) |
| Status | Terminated |
| Reason | Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date. |
| Root cause | Other |
| Action | Firm sent modified operating instructions to users on 13 February 2004. |
| Quantity | 390 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.