FDA Medical devices recall ·
DxC 500 AU Clinical Chemistry Analyzer recall
- Recall number
- Z-1233-2025
- Date
- (initiated January 10, 2025)
- Company / brand
- Beckman Coulter Laboratory Systems (Suzhou) CO., Ltd.
No. 11 Shengpu Street Zhensheng Road, Suzhou, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 56
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
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
US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea
States: Alabama California Colorado Georgia Idaho Illinois Louisiana Massachusetts Michigan Minnesota Mississippi New York Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1233-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.