Company:Beckman Coulter Inc
Date of Enforcement Report 8/3/11
Class ll:
PRODUCT
1) Beckman Coulter UniCel DxI 800 Access Immunoassay System with UniCel DXI system software version 4.3. Part Numbers: A71456, 973100, A25288, A25285. Recall # Z-2685-2011;
2) Beckman Coulter UniCel DxI 600 Access Immunoassay System, Part Numbers: A71460 and A30260 with UniCel DXI system. Recall # Z-2686-2011
REASON
Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running UniCel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type setting will reset to the previously saved setting when power is interrupted to the system, or if an operator reboots the system. If the default sample type is set to urine while running software version 4.3, the system will reset to the previously saved sample type setting, serum, when the power is interrupted or the system is rebooted. For an LIS test request with no specified sample type, the system applies the previously saved default sample type setting to the test request even if the system was not rebooted. A test result could be reported with ranges or a unit of measure corresponding to the previously saved sample type setting. Ranges may include references ranges, critical ranges, and LIS ranges defined on the DXI.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on July 6, 2010.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
794 units
DISTRIBUTION
Nationwide and Canada
