Health product recall

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

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

VIDAS - Varicella-Zoster Virus (VZG) Assay

Lot or serial number

1007410330

Model or catalog number

30217

Companies
Manufacturer

BioMérieux S.A

376 Chemin De L'orme

Marcy-l'etoile

69280

FRANCE