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.
This recall is currently active, issued July 31, 2024. It was issued by Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan.
- Recall Initiated
- June 5, 2024
- Posted
- July 31, 2024
- Recall Number
- Z-2455-2024
- Quantity
- 24 analyzers
- Official Source
- View on FDA website ↗
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.
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.
Lot / 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
Root Cause
Software design
Action Taken
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