| | Class 2 Device Recall DxC 500i Clinical Analyzer |  |
| Date Initiated by Firm | August 04, 2025 |
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| Date Posted | October 02, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0032-2026 |
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| Recall Event ID |
97390 |
| 510(K)Number | K242190 |
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| Product Classification |
Radioimmunoassay, cortisol - Product Code CGR
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| 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 |
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| Code Information |
REF/UDI-DI:
C63522/14987666545089, C63521/14987666545072.
Software Versions: SW 1.3.3 and 1.3.4
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Recalling Firm/
Manufacturer |
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
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| For Additional Information Contact |
714-961-5321 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Software Design Change |
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| Action | 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 |
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| Quantity in Commerce | 116 |
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| 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
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = CGR
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