Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay
Brand(s)
Last updated
Summary
Product
Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay
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 catalog number |
|---|---|---|
| Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay | All lots. | OSR6237 OSR6137 |
| Beckman Coulter Au2700 Immunochemistry System - Bicarbonate(CO2) Assay | All lots. | OSR6237 OSR6137 |
| Beckman Coulter Au5400 Immunochemistry System - Bicarbonate (CO2)Assay | All lots. | OSR6237 OSR6137 |
Issue
Beckman Coulter has confirmed a premature decrease in calibration ODs for several lots of bicarbonate OSR6X37. It is possible that all bicarbonate lots may also be impacted by this issue, therefore all lots are subject to this field action.
The abnormal decrease in calibrator ODs may result in calibration failures and/or OC failures. the risk of generating falsely elevated, clinically impactful patient test results is remote.
Recall start date: April 3, 2023
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-73500
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