DxC 500 AU Clinical Chemistry Analyzer — Class II medical device recall Z-2455-2024
Ongoing recall by Beckman Coulter Mishima K.K., reported 2024-08-07, distributed nationwide. There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibratio
| Recall number | Z-2455-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Mishima K.K., Sunto-Gun, N/A, Japan |
| Recall initiated | 2024-06-05 |
| Classified | 2024-07-31 |
| Reported by FDA | 2024-08-07 |
| 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
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
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-2455-2024. 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.