BD Kiestra" ReadA — Class II medical device recall Z-1658-2026
Ongoing recall by BD KIESTRA LAB AUTOMATION, reported 2026-04-08, distributed in KS, MD, MN, NJ, TX, VA. In certain situations, following a system reboot, one or more modules may have become unreachable via the remo
| Recall number | Z-1658-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD KIESTRA LAB AUTOMATION, Drachten, Netherlands |
| Recall initiated | 2026-02-06 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | KS, MD, MN, NJ, TX, VA |
| Countries outside the US | AT, AU, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, IT, KW, MA, MX, NL, NO, SA, SE, TW |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00382904469481 |
| Model numbers | 446948 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1658-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.