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.
Recall
- Recall Number
- Z-2455-2024
- Event Number
- 94820
- Firm
- Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan
- FEI Number
- 3002807663
- Product Code
- JJE
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- June 5, 2024
- Posted
- July 31, 2024
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.
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.
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
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.
24 analyzers