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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

BD Kiestra ReadA Lab Automation Recalled for Software Connectivity Issue

Agency Publication Date: March 27, 2026
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Summary

BD Kiestra is recalling 82 units of the BD Kiestra ReadA lab automation system because some modules can become unreachable after a system reboot. This software issue can cause delays in retrieving sample plates from the incubator while technicians work to restore connectivity. This recall affects 7 units in the United States and 65 units internationally, covering all serial numbers for catalog number 446948.

Risk

A loss of remote connectivity can delay the retrieval of incubated samples, which could potentially slow down laboratory testing workflows. The manufacturer has stated that this intermittent issue does not affect the accuracy of test results, the performance of assays, or the integrity of the samples.

What You Should Do

  1. Identify if your laboratory is using the BD Kiestra ReadA system with Catalog Number 446948 and UDI-DI 00382904469481.
  2. Check the serial number on your device label; this recall affects all serial numbers for the specified catalog number.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Kiestra ReadA
Model / REF:
446948
Serial Numbers:
All
UDI:
00382904469481

Recall #: Z-1658-2026; 82 units affected (7 US, 65 OUS).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98473
Status: Active
Manufacturer: BD KIESTRA LAB AUTOMATION
Sold By: Direct from manufacturer
Manufactured In: Netherlands
Units Affected: 82 units (7 US, 65 OUS)
Distributed To: Kansas, Maryland, Minnesota, New Jersey, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.