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

Company / brand

BD KIESTRA LAB AUTOMATION

Product

BD Kiestra" ReadA; Catalog No.: 446948.

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / 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;

Recall initiated

2026-02-06

Code info

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

Product quantity

82 units (7 US, 65 OUS)

Voluntary mandated

Voluntary: Firm initiated

City

Drachten

Country

Netherlands

Event id

98473

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