April 8, 2026Medical DevicesFDA
BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA; Catalog No.: 446948.
Hazard: In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.