Reported Apr 8, 2026 · Ongoing

BD Kiestra" ReadA; Catalog No.: 446948.

Bd Kiestra Lab Automation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BD KIESTRA LAB AUTOMATION · Marconilaan 6 · Drachten · N/A

Is this the product you have?

  • BD Kiestra" ReadA; Catalog No.: 446948.
Lot codes and dates
  • Catalog No.: 446948
  • UDI-DI00382904469481
  • Serial NumbersAll
Amount recalled
82 units (7 US, 65 OUS)

Where it was sold

Why it was recalled

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 product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

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