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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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.
In certain situations after a system reboot, one or more modules may 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. The issue is intermittent and did not affect test results, performance of the assay, or sample integrity.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow recall instructions provided by the manufacturer. 3. Contact BD Kiestra Lab Automation or your healthcare provider for instructions. 4. Refund contact info: Unknown.
Phone: Unknown Website: Unknown Hours: Unknown
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