BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA; Catalog No.: 446948.

Recall date

February 6, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1658-2026

FDA classification

Class II

Brand / firm

BD KIESTRA LAB AUTOMATION

Sold / distributed

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;

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Kiestra" ReadA; Catalog No.: 446948.