Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.

Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.

An Urgent Medical Device Recall letter dated 5/17/16 was sent to customers to inform them that Beckman Coulter is recalling the Access 2 Immunoassay System, Remanufactured instrument, because it may not have all the updated thermal components installed. The letter informs customers of the impact and actions to be taken. The letter informs the customers that their Service Representative will contact them to schedule an onsite visit to inspect their instrument and update as needed. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers outside the United States and Canada are instructed to contact their local Beckman Coulter representative.