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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, Inc.: Microscopy Analyzers Recalled Due to Potential for Erroneous Results from Rust

Agency Publication Date: January 25, 2024
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Summary

Beckman Coulter has recalled 384 units of various microscopy analyzers and spare parts, including the DxU 850m/840m and iQ200 series, due to a defect where the internal cannula may rust. This rusting occurs in the Flowcell and the iQClear Rinse Waste Well Assembly and can interfere with the device's performance. The presence of rust has the potential to cause the machines to generate incorrect or erroneous diagnostic results, which could impact patient care decisions. These medical devices were distributed globally between December 2023 and January 2024.

Risk

Rust forming on the internal cannula can contaminate the fluid path of the microscopy analyzer, leading to inaccurate diagnostic data or false readings during urine and blood microscopy analysis. No specific injuries have been reported, but erroneous medical results can lead to delayed or inappropriate clinical treatments.

What You Should Do

  1. Identify if your laboratory or facility uses the Beckman Coulter DxU 850m/840m (Part Numbers C49513, C76947) or iQ200 Series Urine Microscopy Analyzers (Part Numbers 700-3320, 700-3370, 700-3345, 700-3347, C10683, 700-3375, 700-3325, or C10684).
  2. Check for affected spare parts including the REV 2 Flowcell Capsule Spare (Part Number C04154, UDI/DI 15099590689452) and the iQ Waste Well Adapter (Part Number 700-3393, UDI/DI 15099590706180).
  3. Inspect devices for any signs of rust within the Flowcell or the iQClear Rinse Waste Well Assembly and immediately contact Beckman Coulter to discuss the integrity of recent results if rust is found.
  4. Contact your healthcare provider or Beckman Coulter at 1-800-526-3821 or through their website at www.beckmancoulter.com for further technical instructions, component replacement, or troubleshooting guidance.
  5. For additional information or to report adverse events, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for technical inspection and replacement of rusted components.

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

Affected Products

Product: Beckman Coulter DxU 850m/840m Microscopy Analyzers
Model / REF:
C49513
C76947
UDI/DI 15099590748647
UDI/DI 15099590748654
Lot Numbers:
All serial numbers
Product: iQ200 Series Urine Microscopy Analyzers
Model / REF:
700-3320
700-3370
700-3345
700-3347
C10683
700-3375
700-3325
C10684
UDI/DI 10837461001188
UDI/DI 10837461001324
UDI/DI 10837461001300
UDI/DI 10837461001317
UDI/DI 15099590697129
UDI/DI 10837461001355
UDI/DI 10837461001256
UDI/DI 15099590695484
Lot Numbers:
All serial numbers
Product: REV 2 Flowcell Capsule Spare
Model / REF:
C04154
UDI/DI 15099590689452
Lot Numbers:
All lot numbers
Product: iQ Waste Well Adapter
Model / REF:
700-3393
UDI/DI 15099590706180
Lot Numbers:
All lot numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93655
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Authorized medical device distributors; Direct sales from Beckman Coulter, Inc.
Manufactured In: United States
Units Affected: 4 products (254 units; 112 units; 16 units; 2 units)
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.

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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.