The Recall Desk
ModerateFDA (Devices)·Z-1658-2026·Announced 2026-04-08

BD Kiestra ReadA modules may be unreachable after a system reboot

BD is recalling the Kiestra ReadA because after a system reboot one or more modules may become unreachable via the remote connectivity interface, delaying plate retrieval.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers low-risk, precautionary recalls: the source states the fault was intermittent and did not affect test results, assay performance or sample integrity, leaving only an operational delay.

Plain-English summary

BD Kiestra ReadA, catalogue number 446948, is being recalled. About 82 units were distributed, 7 in the United States across six states and 65 outside it, to more than twenty countries. The FDA has classified this recall as Class II.

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. The firm states the issue was intermittent and did not affect test results, performance of the assay, or sample integrity.

Affected product is identified by catalogue number 446948.

Laboratories can identify affected units by the catalogue number above, and may contact the recalling firm for further information.

The recalled product

Product
BD Kiestra" ReadA; Catalog No.: 446948.
Manufacturer
BD KIESTRA LAB AUTOMATION
Category
Medical Device — Laboratory automation
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Catalog No.: 446948
  • UDI-DI: 00382904469481
  • Serial Numbers: All

Distribution

Distributed in 6 states:

Related recalls

Same hazard · connectivity loss

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