UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

Reason: When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

Code information: Systems running software versions: 5.2, 5.3.0, 5.3.1.

Distribution pattern: US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany, Greece, India, Italy, Malaysia, Morocco, Netherlands, Nigeria, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, Tunisia, United Kingdom, United States, Vietnam