FDA Device recall Z-1658-2026
BD Kiestra" ReadA
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of BD Kiestra" ReadA by Bd Kiestra Lab Automation, citing 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 fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1658-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-06 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Bd Kiestra Lab Automation |
| Distribution | KS, MD, MN, NJ, TX, VA |
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.
Identifiers
| code_info | Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1658-2026%22
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