FDA Device recall Z-1233-2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software
- FDA Device
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software by Beckman Coulter Laboratory Systems Suzhou, citing 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 p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1233-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-10 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter Laboratory Systems Suzhou |
| Distribution | AL, CA, CO, GA, ID, IL, LA, MA, MI, MN, MS, NY, OK, OR, PA, PR, SC, TX, WA |
Product
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Reason
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.
Identifiers
| code_info | Software Versions: V1.4, V1.4.1, V1.4.2, V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170; C63520/1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1233-2025%22
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