Beckman Coulter Inc.: Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

Agency Publication Date: March 15, 2017

Affected Products

Product: Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Serial No. 511527 - 511678; 511681 - 512212

Product: Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Serial No. 501012,501110,501190,501224,501294,501371,501394,501403,501440, 501443,501490,501501,501673,501681,501693,501861,501920,501926, 501936,501970,502165,502196,502319,502331,502332,502368,502458, 502475,502506,502543,502549,502556,502574,502640,502647,502651, 502791,502843,502848,503153,503279,503313,503354,503384,503392, 503424,503543,503627,503678,504046,504071,504072,504092,504112, 504195,504322,504365,504370,504756,504767,504902,505042,505195, 505251,505254,505644,505795,505840,505947,506002,506026,506108, 506119,506153,506187,506371,506406,506560,506586,506664,506708, 506766,506786,506837,506846,507039,507120,507161,507162,507214, 507229,507248,507282,507353,507397,507480,507511,507604,507619, 507842,507929,508019,508096,508179,508227,508313,508334,508412, 508478,508509,508516,508767,509051,509087,509113,509164,509253, 509297,509632,509837,510049,511042,511047,511180,511383,700024, 800321,800341,800443,800608,800611,800650,800849

Product: UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Serial No. (Part No. A25637) 800999,801019 Serial No. (Part No. A25638)800995,800996,800997,800998,801000,801001,801002,801003,801004, 801005,801006,801007,801008,801009,801010,801011,801012,801013, 801014,801015,801016,801017,801018,801020,801021,801022,801023, 801024,801025,801026,801027

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76688

Status: Resolved

Manufacturer: Beckman Coulter Inc.

Manufactured In: United States

Units Affected: 3 products (851 units total for all products (291 units in US))

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Sources: FDA iRES · Raw API Response

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Affected Products

Serial No. 511527 - 511678; 511681 - 512212