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Beckman coulter au immunochemistry system - bicarbonate (co2) assay
Official notice
13 Apr 2023
Last checked
13 Apr 2023
An official Health Canada notice concerns Beckman coulter au immunochemistry system - bicarbonate (co2) assay. 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 Published 2023-04-13.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73500
Official notice
2023-04-13
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
Company & contacts
Company & contacts
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Brand: Beckman Coulter, Beckman Coulter Au Immunochemistry System - Bicarbonate Assay.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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