DxC 500 AU Clinical Chemistry Analyzer — Class II medical device recall Z-2691-2024
Ongoing recall by Beckman Coulter Mishima K.K., reported 2024-08-28, distributed nationwide. Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with sam
| Recall number | Z-2691-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Mishima K.K., Sunto-Gun, Japan |
| Recall initiated | 2024-07-10 |
| Classified | 2024-08-21 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | LB, ZA |
| Quantity | 24 analyzers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 14987666545065 |
| Serial numbers | 2023060005, 2023070009, 2023070010, 2023080011, 2023080012, 2023090015, 2023090016, 2023100018, 2023100019, 2023100020, 2023110022, 2023110023, 2024010024, 2024010025, 2024010036, 2024010037, 2024010038, 2024020039, 2024020040, 2024020041, 2024020042, 2024020043, 2024020045, 2024020046 |
| Model numbers | C63520 |
Product
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 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 for recall
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2691-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.