Health product recall

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

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

VIROTROL HIV-2

Lot or serial number

Lot# 114730 Exp: 30-NOV-2019

Model or catalog number

00105B

Companies
Manufacturer
Bio-Rad Laboratories
9500 Jeronimo Road
Irvine
92618
California
UNITED STATES