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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

Beckman Coulter Biomedical GmbH: Power Express Sample Holders Recalled for Detachment and Biohazard Risk

Agency Publication Date: September 5, 2024
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Summary

Beckman Coulter is recalling the Power Express Sample Holder and its associated PE Centrifuge components (Models B90918, B36365, and B36366). An adhesive joint within the sample holder can fail, causing a metal piece to detach and enter the centrifuge while it is spinning. This defect can destroy patient samples, leading to significant delays in medical results and potentially exposing laboratory technicians to biohazardous materials if the equipment is damaged. All serial numbers for the affected models are included in this recall.

Risk

If the metal component detaches during operation, it can damage the centrifuge and break open containers holding patient specimens. This creates a risk of laboratory staff being exposed to hazardous biological materials and may lead to incorrect or delayed medical diagnoses due to the destruction of samples.

What You Should Do

  1. Identify if your laboratory uses the Power Express (REF B90918), PE Centrifuge (REF B36365), or PE Centrifuge Temperature Controlled (REF B36366).
  2. Verify your equipment against the following UDI numbers: (01)15099590681555, (01)15099590673550, or (01)15099590673567. All serial numbers are affected.
  3. Immediately contact Beckman Coulter Biomedical GmbH to report your possession of the affected equipment and to receive specific instructions regarding the adhesive joint failure.
  4. Consult with your facility's safety officer regarding potential exposure risks and protocols if sample destruction has occurred.
  5. Contact the manufacturer or your healthcare provider for further instructions on equipment repair and potential reimbursement for damaged components.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact the manufacturer for technical instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Power Express
Model / REF:
REF B90918
Lot Numbers:
UDI: (01)15099590681555
All serial numbers
Product: PE Centrifuge
Model / REF:
REF: B36365
Lot Numbers:
UDI: (01)15099590673550
All serial numbers
Product: PE Centrifuge Temperature Controlled
Model / REF:
REF: B36366
Lot Numbers:
UDI: (01)15099590673567
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95064
Status: Active
Manufacturer: Beckman Coulter Biomedical GmbH
Sold By: Beckman Coulter Biomedical GmbH; Authorized medical device distributors
Manufactured In: Germany
Distributed To: Nationwide

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.