Product Wiki · Recalls · Health Canada — Medical Devices

Cobas AmpliPrep/Cobas TaqMan HCV Quantitative & Qualitative Test… — recall 48026

Health Canada — Medical Devices · Canada · 2019-12-06 · Type III

As described by Health Canada — Medical Devices: Cobas AmpliPrep/Cobas TaqMan HCV Quantitative & Qualitative Test, V2.0 (2019-10-23)

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Agency
Health Canada — Medical Devices
Recall identifier
48026
Date of alert
2019-12-06
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Potential of over-quantified false positive results with the Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) HCV Test, V2.0 CE- IVD caused by abnormal curve shape. This situation is corrected with the updated test definition file (TDF) versions for the Cobas AmpliPrep/Cobas TaqMan HCV Test, V2.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-ampliprepcobas-taqman-hc

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