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.

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.

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 until the modification is completed, the system should be operated in a room temperature of 20C to 30C. This can be acomplished by monitoring and recording room tamperature in the area of the instrument. Customers are also asked to review historical quality control records to ensure assay performance is within their laboratory specification and that patient results should be reviewed in context of other diagnostics tests and the clinical presentations of the patient. A response form is included.