Device 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.
Z-1710-2017
Product summary
- Event
- Event 76688
- Status
- Terminated
- Classification
- Class II
- Quantity
- 851 units total for all products (291 units in US)
- Official record key
device-enforcement:Z-1710-2017
Official wording
Reason: 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.
Code information: 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
Distribution pattern: Affected geographies: Algeria, Austria, Australia, Bangladesh, Bulgaria, Brazil, Canada, China, Costa Rica, Cyprus, Colombia, Czech Republic, El Salvador, France, Germany, Ghana, Greece, Guatemala, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malawi, Mexico, Morocco, Myanmar, Nepal, Oman, Panama, Philippines, Pakistan, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Tunisia, Turkey, United Kingdom, United States, Vietnam, Zimbabwe
Derived failure modes
-
Unknown
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.