DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module recallZ-0032-2026 · Beckman Coulter Inc. · initiated Aug 4, 2025
Class II Open, Classified All recalls posted in October 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Design Change
What the company is doing
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: [email protected] 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
Recall details
- Recall number
- Z-0032-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 4, 2025
- Posted by the FDA
- Oct 2, 2025
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 116
- Product code
- CGR
- FDA submissions
- K242190
- Distribution
- Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of Korea
Product description
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
Code information (models, lots, serial numbers)
REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63522Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use4 recalls5 reports
- DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module C63521Beckman Coulter, Inc. · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use4 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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