ProductGuru Recalls

Official recall record

BD Kiestra" ReadA; Catalog No.: 446948.

US FDA — Medical Devices · 2026-02-06 · NetherlandsClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2026-02-06
Country of alert
Netherlands
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
00382904469481
Brand on record
BD KIESTRA LAB AUTOMATION

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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