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U.S. Department of Health and Human Services

Class 2 Device Recall DxC 500 AU Clinical Chemistry Analyzer

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 Class 2 Device Recall DxC 500 AU Clinical Chemistry Analyzersee related information
Date Initiated by FirmJuly 10, 2024
Date PostedAugust 21, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2691-2024
Recall Event ID 95018
510(K)NumberK220977 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductDxC 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
Recalling Firm/
Manufacturer		 Beckman Coulter Mishima K.K.
454-32
Higashino; Nagaizumi-Cho
Sunto-Gun Japan
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
Actionduring 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 in Commerce24 analyzers
DistributionWorldwide - 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.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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