FDA Medical Device Recalls (openFDA)
Beckman Coulter Mishima K.K.: 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 number
- Z-2691-2024
- 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.
- Status
- Open, Classified
- Initiated
- 2024-07-10
- Posted
- 2024-08-21
- Terminated
- not on file
- Reason
- Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
- Root cause
- Software design
- Action
- during the week of 07/25/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter via email and postal mail to customers informing them that after the analyzer processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and an error code "9000" will be reported. Customer are instructed: . Monitor the rerun/reflex process if a rerun/reflex rack is held in the buffer area, manually retrieve the rack from the buffer area, manually order the rerun/reflex test and reload the sample onto the sample handler. Refer to Rerunning a Test section of the Instructions for Use on page 10-34. Beckman Coulter has implemented the correction with software V1.4 which was released on 06/21/2024. A Beckman Coulter service representative will contact customers to schedule the software upgrade. For any questions or assistance - contact the Beckman Coulter Customer Support via email https://www.beckmancoulter.com/en/support/contact-us
- Quantity
- 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, South Africa.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K220977"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3002807663
- Firm city
- Nagaizumi-Cho Sunto-Gun
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28