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Recall Observatory FDA recall evidence

Device product

BD Kiestra" ReadA; Catalog No.: 446948.

Z-1658-2026

February 06, 2026

Class II

Product summary

Firm
BD KIESTRA LAB AUTOMATION
Event
Event 98473
Status
Ongoing
Classification
Class II
Quantity
82 units (7 US, 65 OUS)
Official record key
device-enforcement:Z-1658-2026

Official wording

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.

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

Distribution pattern: 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;

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.