Recall Z-0471-2007 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc
Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers
| Date | Jan 9, 2007 (initiated Nov 1, 2006) |
| Status | Terminated |
| Reason | The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. This issue is limited to only protocols utilizing the Ratio parameter. |
| Root cause | Other |
| Action | A Product corrective Action (PCA) letter was mailed on 11/1/06 to Expo 32 software accounts. They are informed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialogue box is accessed. The issue is limited to only protocols utilizing the Ratio parameter. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter: 1) Perform acquisition of samples in batches which use protocols containin |
| Quantity | 28 units |
| Distribution | Nationwide including the states of MA, AL, CO, MI, IN, MD, MO NY, PA, TX, AR, CA, NJ, FL, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.