Z-2455-2024Class II

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes...

Name: Z-2455-2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes...
Creator: Beckman Coulter Mishima K.K.
Published: 2024-06-05
License: https://open.fda.gov/license/

Beckman Coulter Mishima K.K. / initiated 2024-06-05 / Open, Classified / root cause: software

FDA source

Beckman Coulter Mishima K.K. began a recall of DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate... on 2024-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2455-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-05
Posted: 2024-07-31
Recalling firm: Beckman Coulter Mishima K.K.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2455-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2455-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-31

Product code JJE

K220977Class IIISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. / cleared 2023-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)