[Recalled] BD Kiestra" ReadA; Catalog No.: 446948. — In certain situations, following a system reboot, one or more modules may have… | FDA 2026-02-06
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | BD Kiestra" ReadA; Catalog No.: 446948. |
|---|---|
| Brand / manufacturer | BD KIESTRA LAB AUTOMATION |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1658-2026 |
| Country of notice | Netherlands |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 06 February 2026 |
| EAN / barcode | 00382904469481 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Netherlands and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.