Company:Beckman Coulter Inc.
Date of Enforcement Report 5/18/2011
Class ll:
PRODUCT
1) UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1938-2011;
2) UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1939-2011;
3) UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903, DxC860i: A64935, DxC 880i: A59102 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. Recall # Z-1940-2011
REASON
The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the two was not scanned. This is referred to as a “pushed pair.” If a pushed pair event occurs, results may be associated with the incorrect patient identification. The association of results with the incorrect patient identification may lead to misdiagnosis, inappropriate testing, inappropriate treatment, and/or delayed treatment.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, letter dated January 26, 2011.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2639 units (892 in US)
DISTRIBUTION
Nationwide and Internationally
