DxC 500i Clinical Analyzers
Brand(s)
Last updated
Summary
Product
DxC 500i Clinical Analyzers
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| DxC 500i Clinical Analyzer, DxC 500i Au Chemistry Module | software 1.3.3 or 1.3.4 | C63522 |
| DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module | software 1.3.3 or 1.3.4 | C13252 |
Issue
Beckman Coulter has determined that on the DxC 500i 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 constituent tests, the sample status of the CC test will remain "in progress" with no error events.
Recall start date: August 4, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Beckman Coulter, Inc. |
| 250 S. Kraemer Blvd., Brea, California, United States, 92821 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77931
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