Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1658-2026 — BD Kiestra" ReadA; Catalog No.: 446948.

U.S. FDA — Device Enforcement · Netherlands · 2026-02-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1658-2026
Date of alert
2026-02-06
Country / jurisdiction
Netherlands
Risk level
Class II
Risk type
recall
Brand
BD KIESTRA LAB AUTOMATION
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00382904469481
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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