Class 2 Device Recall DxC 500 AU Clinical Chemistry Analyzer

• Date Initiated by Firm: June 05, 2024
• Date Posted: July 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2455-2024
• Recall Event ID: 94820
• 510(K)Number: K220977
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• 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.
• Code Information: 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
• FEI Number: 3002807663
• Recalling Firm/ Manufacturer: Beckman Coulter Mishima K.K.; 454-32; Higashino; Nagaizumi-Cho; Sunto-Gun Japan
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: 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
• Quantity in Commerce: 24 analyzers
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JJE