DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer
Brand(s)
Last updated
Summary
Product
DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer
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 Access 2 Immunoassay Module | More than 10 numbers, contact manufacturer. | C11137 |
| DxI 9000 Access Immunoassay Analyzer | More than 10 numbers, contact manufacturer. | C13252 |
Issue
Beckman Coulter has confirmed a software anomaly on the DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results (R1, R2) and potential delays in reporting (R3), risking erroneous diagnoses if undetected
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
Recall date
Identification number
RA-78147
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