BD Kiestra recalled 82 units of its ReadA lab automation module on February 6, 2026, including 7 in the United States and 65 overseas. The issue arises after a system reboot when one or more modules become unreachable via the remote connectivity interface, potentially delaying plate retrieval from the incubator. The problem is intermittent and did not affect test results, assay performance, or var
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BD KIESTRA LAB AUTOMATION or your healthcare provider for instructions. Notification method: Letter
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BD Kiestra ReadA is part of the BD Kiestra Lab Automation system used in clinical microbiology labs to automate plate incubation and processing.
An intermittent connectivity issue after reboot can render modules unreachable via the remote interface, causing delays in plate retrieval from the incubator. The issue has not affected test results, assay performance, or sample integrity.
This recall is not described as part of a broader industry pattern.
Delays in plate retrieval may affect workflow and turnaround times in busy labs. There is no reported impact on test accuracy or sample integrity.
On the device label, recall notification, and FDA recall page linked to the notice.
Not specified by the manufacturer.
Keep the recall notification, device identifiers, distribution records, and all correspondence with the manufacturer for audit trails.
Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All; Quantity: 82 units (7 US, 65 OUS); Domestic distribution: KS, MD, MN, NJ, TX, VA; International distribution: 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 date: 2026-02-06; Company: BD Kiestra Lab Automation; Status: ACTIVE.
No injuries or incidents have been reported.
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