FDA-Device2026-04-08Class II

BD Kiestra" ReadA; Catalog No.: 446948.

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.

Sold states

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;

Affected count

82 units (7 US, 65 OUS)

Manufactured in

Marconilaan 6, Drachten, Netherlands

Products

BD Kiestra" ReadA; Catalog No.: 446948.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1658-2026

Original summary

BD Kiestra" ReadA; Catalog No.: 446948. 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. Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All; 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; Affected quantity: 82 units (7 US, 65 OUS)

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