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Beckman Coulter Inc. recalls UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System
Recalled November 28, 2012 · FDA recall Z-0346-2013 · Beckman Coulter
Hazard
The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. · FDA Class II
Units
432 units
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR, AT, BE, CO, DZ, FI, IE, IL, KR, KW, LI, NA, NO, NZ, PF, PH, PR, SE, SG, SZ, TH, TW, VE, VN, and YT.
Description
The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
Product
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel 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. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →