Recall Z-0583-06 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc
UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
| Date | Mar 3, 2006 (initiated Feb 6, 2006) |
| Status | Terminated |
| Reason | The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances) |
| Root cause | Software design |
| Action | A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail) |
| Quantity | 280 total (263 in US & 17 in Canada) |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 Beckman Coulter, Inc., Jan 28, 2003 |