DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Summary
The FDA issued a Class II for DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 by Beckman Coulter Inc.. Reason: Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a.
Details
Source
Device Recall
External ID
Z-0084-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Lot/Code Info: Software version 1.4.5 or earlier. 1. UDI-DI 14987666545058 2. UDI-DI 14987666545065
Quantity Affected: 146 US, 170 OUS
Reason for Recall
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-02
Company
Brea, CA
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 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Beckman Coulter Inc. has 154 FDA actions in our database, including 107 recalls and 47 clearances.
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 Inc.) 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 Inc. have FDA actions?
Beckman Coulter Inc. has 154 FDA actions in our database, including 107 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0084-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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