FDAFebruary 6, 2026device

BD Kiestra" ReadA; Catalog No.: 446948.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

bd kiestra lab automation

UPCs

00382904469481

Recall history

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