PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 28, 2012 Initiated: August 1, 2011 #Z-0346-2013

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Beckman Coulter Inc.
Units Affected
432 units
Distribution
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.
Location
Brea, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 432 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0346-2013.

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