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Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay — recall 73500

Health Canada — Medical Devices · Canada · 2023-04-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73500
Date of alert
2023-04-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-immunochemi

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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