VITEK 2 Compact 30 System - Instrument (2017-03-02)

Starting date:

March 2, 2017

Posting date:

April 3, 2018

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-66306

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  Reason
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  Affected products

Affected products

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT

Reason

Several complaints were received for invalid calibration with low calibrator s1 while using VIDAS LH. Furthermore, tests performed internally confirmed a decrease of the strips signal overtime for the lot 1006041540. The defect was highlighted with complaints for invalid calibration, but concerns all tests performed (calibration, and patient's samples testing). The investigation concluded that this could have an impact on patient's results.

Affected products