FDA-Device2026-04-08Class IIPROCESSING DEFECT

BD Kiestra ReadA lab automation system recalled for connectivity issues after reboot

Check BD Kiestra ReadA system connectivity

BD Kiestra ReadA lab automation systems (Catalog No. 446948) may occasionally lose remote connectivity after a system reboot, which could temporarily delay plate retrieval from the incubator. The issue is intermittent and does not affect test results, assay performance, or sample integrity. This affects 82 units distributed across the United States and internationally.

If you operate a BD Kiestra ReadA system, contact BD for guidance on your specific unit and any available updates or fixes
Monitor system connectivity after any reboots and manually verify module status if needed
Report any connectivity issues to BD immediately

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

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