BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA

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.

BD Kiestra" ReadA; Catalog No.: 446948.

On February 6, 2026 customers were contacted via phone call with a follow-up URGENT: Medical Device Correction letter were sent to customers on or about March 10, 2026. Actions to be taken: 1. Ensure the contents of this notification are read and understood. 2. Share and post this customer letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088)

• FDA enforcement recordOfficial FDA database entry for Z-1658-2026
• FDA device classification · JTQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2540The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find BD KIESTRA LAB AUTOMATIONSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.