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

Starting date:

November 28, 2019

Posting date:

December 13, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71875

Last updated: 2019-12-13

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  Reason
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  Affected products

Affected Products

VIDAS - Varicella-Zoster Virus (VZG) Assay

Reason

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.

Affected products