Company: Beckman Coulter Inc.
Date of Enforcement Report 5/11/2011
Class ll:
PRODUCT
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: – Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood – Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-2128-2011
REASON
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths places (comma, “,”) and partial units (decimal, “.”). An LIS that uses non-US formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid results. For example, if the LIS format uses commas to denote partial units, the figure transmitted as “1,586” (one thousand five hundred eighty-six) could be interpreted at the LIS as “1,6” (one and six tenths). IMPACT: Specimens with Body Fluid results ~1000 cells/uL could be reported erroneously low in the LIS. The impact of erroneously low results could be most severe in relation to cerebral spinal fluid (CSF) analysis. This could potentially result in a misdiagnosis or a delay in diagnosis that could affect patient management leading to permanent injury. A long-term delay in the diagnosis of an acute event may result in neurological sequelae such as acute meningitis or cerebral hemorrhage.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
422 units
DISTRIBUTION
Nationwide and Internationally
