Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay |
All lots. |
OSR6237 |
Beckman Coulter Au2700 Immunochemistry System - Bicarbonate(CO2) Assay |
All lots. |
OSR6237 |
Beckman Coulter Au5400 Immunochemistry System - Bicarbonate (CO2)Assay |
All lots. |
OSR6237 |
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
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
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