Medical Device Recall: BD Kiestra" ReadA; Catalog No.: 446948.
BD KIESTRA LAB AUTOMATION · February 6, 2026
Reason for Recall
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.
Distribution
Domestic: KS, MD, MN, NJ, TX, VA; International: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom;
States Affected
KS, MD, MN, NJ, TX, VA
Quantity Affected
82 units (7 US, 65 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1658-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.