DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl
Summary
The FDA issued a Class II for DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry by Beckman Coulter Mishima K.K.. Reason: Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held.
Details
Source
Device Recall
External ID
Z-2691-2024
Action Date
2024-08-28
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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
Quantity Affected: 24 analyzers
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-10
Company
Sunto-Gun
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Mishima K.K. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Mishima K.K.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Mishima K.K. have FDA actions?
Beckman Coulter Mishima K.K. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2691-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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