Recall Z-1184-2008 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc
Beckman Coulter UniCel Dxl 800 Access Immunoassay System; Part Number: 973100 With: UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnostic use.
| Date | Aug 20, 2008 (initiated Oct 8, 2007) |
| Status | Terminated |
| Reason | Incorrect results: There is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18C and 32C operating range. |
| Root cause | Device Design |
| Action | Beckman Coulter mailed a Product Corrective Action (PCA) letter the week of October 8, 2007 to the customers who have the affected UniCel Dxl 800 Access lmmunoassay systems advising that there is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18C and 32C operating range. The letter further advises that Beckman Coulter will contact the customer to arrange a date to remove the modificatlons but |
| Quantity | 111 units in the US; 9 units 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 |