Product Wiki · Recalls · Health Canada — Medical Devices

VIDAS - Varicella-Zoster Virus (VZG) Assay (2019-11-28) — recall 48062

Health Canada — Medical Devices · Canada · 2019-12-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
48062
Date of alert
2019-12-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Following customers complaints for invalid calibration (relative fluorescence value "RFV" calibrator S1 too high and out of RFV range of MLE data) when using one kit of VIDAS VZG (reference 30217) batch 1007410330, an investigation was initiated. The tests confirmed the invalid calibration on the customer's kit with an increase of the calibrator S1 signal.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vidas-varicella-zoster-virus-v

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