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BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA; Catalog No.: 446948.
Recalled April 8, 2026 · FDA recall Z-1658-2026 · BD KIESTRA LAB AUTOMATION
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. · FDA Class II
Units
82 units (7 US, 65 OUS)
Sold at
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;
Description
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.
Product
BD Kiestra" ReadA; Catalog No.: 446948.
Manufacturer(s)
BD KIESTRA LAB AUTOMATION
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →