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BD Kiestra ReadA
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MEDICAL DEVICE RECALLMODERATE

BD Kiestra ReadA

BD Kiestra ReadA is recalled due to potential connectivity issues causing delays in plate retrieval after a system reboot.

What to do

Contact BD Kiestra Lab Automation for technical support or further instructions regarding the system reboot and connectivity restoration.

Recalled
Listed
Updated
Recall No.
Z-1658-2026
Agency
FDA
Firm
BD KIESTRA LAB AUTOMATION
Recall ID
98473
Status
ONGOING

Recall at a glance

Quantity recalled
82 units (7 US, 65 OUS)

Why it was recalled

BD Kiestra ReadA is being recalled because a system reboot may cause modules to become unreachable via the remote connectivity interface. This issue can lead to delays in plate retrieval from the incubator while connectivity is restored, though it does not impact test results, assay performance, or sample integrity.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

BD Kiestra" ReadA; Catalog No.: 446948.

UDI-DI
00382904469481

Where it was sold

Distributed in Kansas, Maryland, Minnesota, New Jersey, Texas, and Virginia.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification