Recall Z-1658-2026— BD KIESTRA LAB AUTOMATION
Class II · Ongoing
Class II FDA medical device recall by BD KIESTRA LAB AUTOMATION, initiated 2026-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Kiestra" ReadA; Catalog No.: 446948.. Reason: 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..
- Recalling firm
- BD KIESTRA LAB AUTOMATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-06
- Firm location
- Drachten, Netherlands
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.