DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Summary
The FDA issued a Class II for DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected so by BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.. Reason: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates .
Details
Source
Device Recall
External ID
Z-1233-2025
Action Date
2025-03-05
Status
Ongoing
Category
device
Product Description
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Lot/Code Info: Software Versions: V1.4, V1.4.1, V1.4.2, V1.4.3 REF/UDI-DI/Serial Numbers: C63519/14987666545058/2024090170; C63520/14987666545065/2024070116, 2023070009, 2024010038, 2024010035, 2024050072, 2024040056, 2024030049, 2024020046, 2024070111, 2024030051, 2024030052, 2024010033, 2023090015, 2024060103, 2024060104, 2024060101, 2024080145, 2024020045, 2024020042, 2024020043, 2024020047, 2024060096, 2024040059, 2023100019, 2024030053, 2023070010, 2024070129, 2024070130, 2024020041, 2024090183, 2024010036, 2024010037, 2024070132, 2024070131, 2023100020, 2024050064, 2024050070, 2023090016, 2023110022, 2024070110, 2024060075, 2024060106, 2023110023, 2024010024, 2024010025, 2024050066, 2024010029, 2024060107, 2023080012, 2024040060, 2024050074, 2024040062, 2024010031, 2024030055, 2024080144
Quantity Affected: 56
Reason for Recall
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Distribution
US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-10
Company
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 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. has 3 FDA actions in our database, including 1 recall and 2 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 LABORATORY SYSTEMS (SUZHOU) CO., LTD.) 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 LABORATORY SYSTEMS (SUZHOU) CO., LTD. have FDA actions?
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1233-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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