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Ortho Vision Analyzers — recall 75367

Health Canada — Medical Devices · Canada · 2024-04-09 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 75367
Date of alert: 2024-04-09
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Haematology
Product type: Medical devices

Reported risk: Due to a wash protocol implementation discrepancy, there is potential for carry over of the Anti-S which may impact results of certain tests after pipetting Anti-S reagent. This issue is intermittent because several factors must interact across a series of events for the false positive to occur. The wash protocol will be updated in the next software release. Recall start date: March 21, 2024

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ortho-vision-analyzers-1

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Ortho Vision Analyzers — recall 75367

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