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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 UniCel DxI Analyzers Recalled for Delayed Patient Results

Agency Publication Date: November 4, 2025
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Summary

Beckman Coulter, Inc. is recalling 737 UniCel DxI 600 and DxI 800 Photometric Chemistry Analyzers. Defective internal components within the gantry assembly can cause motion errors, resulting in the analyzer pausing or entering a "Not Ready" state. This issue leads to significant delays in obtaining medical test results for patients.

Risk

A mechanical failure in the device's movement system causes the analyzer to stop functioning. This poses a risk to patients because critical laboratory results may be delayed, potentially hindering timely medical diagnosis or treatment.

What You Should Do

  1. This recall affects Beckman Coulter UniCel DxI 600 (Part Numbers A71460, A30260) and UniCel DxI 800 (Part Numbers 973100, A71456) Photometric Chemistry Analyzers used in clinical laboratories.
  2. Identify if your analyzer is affected by checking the part number and the serial number located on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately to avoid result delays.
  4. Contact Beckman Coulter, Inc. or your distributor to arrange for an inspection, repair, or replacement of the defective gantry sub-components.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices for additional information regarding this 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: Beckman Coulter UniCel DxI 600 Photometric Chemistry Analyzer
Model / REF:
A71460
A30260
Serial Numbers (80):
902515
902529
902528
902534
902526
902527
902523
902522
902524
902505
902578
902579
902545
902530
902531
902581
902504
902514
902525
902535
902566
902516
902518
902532
902555
902558
902564
902519
902521
902559
902511
902549
902554
902547
902582
902583
902536
902541
902517
902563
902565
902557
902513
902507
902543
902560
902562
902506
902508
902574
UDI:
15099590369224
15099590341602
Product: Beckman Coulter UniCel DxI 800 Photometric Chemistry Analyzer
Model / REF:
973100
A71456
Serial Numbers (553):
610458
610455
610679
610579
610432
610430
610434
610664
610682
610765
610500
610541
610544
610545
610562
610547
610585
610595
610475
610453
610781
610580
610444
610704
610586
610684
610589
610588
610493
610659
610570
610498
610748
610496
610560
610573
610574
610577
610601
610651
610680
610642
610641
610683
610747
610468
610772
610441
610476
610489
UDI:
15099590265373
16954701000412

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97730
Status: Active
Manufacturer: Beckman Coulter, Inc.
Sold By: Authorized Medical Device Distributors; Beckman Coulter, Inc.
Manufactured In: United States
Units Affected: 2 products (80 units; 657 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.

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.