DxC AU recallZ-2455-2024 · Beckman Coulter Mishima K.K. · initiated Jun 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Mishima K.K. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
During the week of June 20, 2024, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via email/postal mail to customers informing them of two software related issues associated with use of the Clinical Chemistry 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. This may cause a false low result or a false high result to be reported to a physician. Issues 2: When a calibration order is manually placed (calibrator lot is not expired) and then the calibrator expires before the calibrator material is placed onto the analyzer for processing, the analyzer will process the expired calibration lot and generate patient results that may be inaccurate, potentially causing a false low result or a false high result to be reported to a physician. Customer are instructed to: For Issue 1 -Follow the IFU Note in Assigning Racks or Calibrator IDs to Calibrators section on pg. 8-7. -Alternatively, change calibrator Load Type to Bar Code Configuration and use barcoded containers for calibration. -Refer to IFU Assigning Racks or Calibrator IDs to Calibrators section on pg. 8-6, and in the software user interface Calibration section, under Calibrations Due Now, review the Load Type configuration, rack ID and cup position set up for the calibrators. Issue 2: -Verify that the calibrator has not expired prior to loading the calibrator material onto the analyzer for processing. -Cancel calibration orders after the calibrator lot material expires. -Repeat any test results generated from a calibration curve that used expired calibrator lot material. For questions/assistance-contact Customer Support Center at http://www.beckmancoulter.com
Recall details
- Recall number
- Z-2455-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2024
- Posted by the FDA
- Jul 31, 2024
- Recalling firm
- Beckman Coulter Mishima K.K.
- Quantity
- 24 analyzers
- Product code
- JJE
- FDA submissions
- K220977
- 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.
Product 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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DxC AU C63520Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use8 recalls17 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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