DxC 500 Analyzer (Beckman Coulter) – test processing issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Products Sold
REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Beckman Coulter Inc. is recalling DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without IS due to On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is proce. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Recommended Action
Per FDA guidance
On 8/4/2025, recall notices were mailed and/or emailed to customers who were asked to do the following: Check your software version, select Menu - About page. - For Clinical Analyzers running software version 1.3.3 or 1.3.4, if this issue occurs, you will need to place a new order for the CC combination test, - Select Home - Sample List task indicator, then select Active in the upper left corner of the Sample List to display samples "In Progress". - Program the CC combination tests for these "In Progress" samples using a new rack and Sample ID, apply the new barcode, then load the rack onto the analyzer for processing. - Set aside the rack with "In Progress" samples and contact your Beckman Coulter representative to clear them. Firm recommends sharing the content of this letter with your laboratory and/or Medical Director. Firm has resolved this issue in Software version 1.3.5 and a firm service representative will contact you to schedule the software upgrade. Share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. Complete and return the response form via email to: regaffairsfax@beckman.com If you have any questions regarding this product, please contact your local firm representative, or use the following link for a listing of local contact information. https://www.beckmancoulter.com/en/support/contact-us
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026