FDA Device recall Z-1517-2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC…
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC… by Beckman Coulter, citing beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1517-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-26 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Reason
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Identifiers
| code_info | Catalog Number: C63519 UDI-DI code: 14987666545058 Serial Numbers: 2024060094 2024070114 2024090174 2024090170 20240701…Catalog Number: C63519 UDI-DI code: 14987666545058 Serial Numbers: 2024060094 2024070114 2024090174 2024090170 2024070118 Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers: 2024010028 2024060085 2024070116 2024080159 2023070009 2024070134 2024090172 2024090199 2024010026 2023110023 2024010024 2024010025 2024080150 2024080152 2024080161 2024090163 2024090165 2024090167 2024060077 2024060082 2024100209 2024090197 2023080011 2024010038 2024050066 2024010035 2024050072 2024040056 2024030049 2024020039 2024020040 2024020046 2024070111 2024030051 2024030052 2024010033 2024100215 2024100203 2023090015 2024100222 2024100224 2024060103 2024060104 2024100207 2024030054 2024060101 2024010029 2024100228 2024080146 2024080138 2024080145 2024060107 2024070113 2024090177 2024090179 2023080012 2024050068 2024040060 2024050074 2024020045 2024070128 2024070119 2024070115 2024020042 2024070120 2024070121 2024070123 2024070124 2024070125 2024070126 2024040062 2024010027 2024080148 2024010 |
|---|
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-1517-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.