Beckman Coulter Mishima K.K. Recall 94820
Description: 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.
Beckman Coulter Mishima K.K. Recall 94820 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2455-2024 |
| Event ID | 94820 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, and South Africa. |
| Quantity | 24 analyzers |
| Recall Reason | 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. |
| Device Classification | 20240807 |
| Device Code Info | Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers: 2023070010 2023060005 2023090015 2023070009 2023080011 2023080012 2023100019 2023100018 2023100020 2024010037 2024010036 2023110022 2024010038 2023090016 2024020040 2024020041 2024020039 2024020043 2024020042 2023110023 2024020045 2024020046 2024010024 2024010025 |
| Center Classification Date | 20240731 |
| Recall Initiation Date | 20240605 |
| Recalling Firm | Beckman Coulter Mishima K.K. |
| Initial Notification | Letter |
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