Recall Z-0315-2008 ยท GKL Counter, Cell, Automated (Particle Counter)
Beckman Coulter Inc
COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer)
| Date | Dec 22, 2007 (initiated Apr 18, 2007) |
| Status | Terminated |
| Reason | Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th |
| Root cause | Software design |
| Action | Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system |
| Quantity | 815 units to the US; 95 units to Canada |
| Distribution | World wide: USA 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 |