BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA

Recalling company

BD KIESTRA LAB AUTOMATION

Product

BD Kiestra" ReadA; Catalog No.: 446948.

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 6, 2026

Reported

Apr 8, 2026

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;

Status

Ongoing

Quantity

82 units (7 US, 65 OUS)

Lot / codes

Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;

Company location

Drachten

Recall type

Voluntary: Firm initiated

Recall number

Z-1658-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1658-2026 in the FDA Enforcement Report. Also see FDA recall press releases.