Product Wiki · Recalls · Health Canada — Medical Devices

ARCHITECT BNP Controls (2019-05-29) — recall 59187

Health Canada — Medical Devices · Canada · 2019-06-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59187
Date of alert
2019-06-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Falsely elevated patient and/or control results may be obtained when using ARCHITECT BNP calibrators and controls. Preliminary investigation has determined that all current in-date BNP calibrator and control lots are impacted by an age dependent shift in performance. Use of impacted calibrator lots may result in falsely elevated patient results. Use of impacted control lots may result in invalid patient results due to controls out of range.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/architect-bnp-controls-2019-05

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