FDA recall Z-1658-2026

BD KIESTRA LAB AUTOMATION · Class II · device

Product

BD Kiestra" ReadA; Catalog No.: 446948.

Reason for recall

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.

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;

Key facts

Status
Ongoing
Initiation date
2026-02-06
Report date
2026-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Drachten, Netherlands

Primary source

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