🔍 RecallPedia

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

Class I - Dangerous
🏥 Medical Devices Recalled: January 10, 2025 BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO. Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software Versions: V1.4, V1.4.1, V1.4.2, V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170; C63520/14987666545065/2024070116, 2023070009, 2024010038, 2024010035, 2024050072, 2024040056, 2024030049, 2024020046, 2024070111, 2024030051, 2024030052, 2024010033, 2023090015, 2024060103, 2024060104, 2024060101, 2024080145, 2024020045, 2024020042, 2024020043, 2024020047, 2024060096, 2024040059, 2023100019, 2024030053, 2023070010, 2024070129, 2024070130, 2024020041, 2024090183, 2024010036, 2024010037, 2024070132, 2024070131, 2023100020, 2024050064, 2024050070, 2023090016, 2023110022, 2024070110, 2024060075, 2024060106, 2023110023, 2024010024, 2024010025, 2024050066, 2024010029, 2024060107, 2023080012, 2024040060, 2024050074, 2024040062, 2024010031, 2024030055, 2024080144
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Reason for Recall:
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

Product Codes/Lot Numbers:

Software Versions: V1.4, V1.4.1, V1.4.2, V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170; C63520/14987666545065/2024070116, 2023070009, 2024010038, 2024010035, 2024050072, 2024040056, 2024030049, 2024020046, 2024070111, 2024030051, 2024030052, 2024010033, 2023090015, 2024060103, 2024060104, 2024060101, 2024080145, 2024020045, 2024020042, 2024020043, 2024020047, 2024060096, 2024040059, 2023100019, 2024030053, 2023070010, 2024070129, 2024070130, 2024020041, 2024090183, 2024010036, 2024010037, 2024070132, 2024070131, 2023100020, 2024050064, 2024050070, 2023090016, 2023110022, 2024070110, 2024060075, 2024060106, 2023110023, 2024010024, 2024010025, 2024050066, 2024010029, 2024060107, 2023080012, 2024040060, 2024050074, 2024040062, 2024010031, 2024030055, 2024080144

Distribution:

Distributed in: US, MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1233-2025