VIROTROL HIV-2 (2019-09-04)

Starting date:

September 4, 2019

Posting date:

September 20, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71021

Last updated: 2019-09-20

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  Reason
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  Affected products

Affected Products

VIROTROL HIV-2

Reason

VIROTROL HIV-2 is intended for use as an unassayed reactive positif control with in vitro assay procedures for determination of antibodies to Human Immunodeficiency Virus Type 2 (HIV-2).We have recently confirmed non-reactive results when using VIROTROL HIV-2, lot 114730 on  Ortho VITROS HIV 1+2 assays.

Affected products