When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Reason for recall: When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment. Distribution: Worldwide distribution. Quantity: 370 units Lot/code info: UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
15099590732103
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.