Health product recall

Vitros Immunodiagnostic Products HIV Combo Reagent Pack

Last updated


Vitros Immunodiagnostic Products HIV Combo Reagent Pack
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalog number
Vitros Immunodiagnostic Products HIV Combo Reagent Pack 0670 0740 0760 0660 0730 0750 684 2779


Scenario 1:
Ortho received a customer complaint for false negative results generated from Vitros HIV combo reagent pack, lot 0670, when testing a proficiency sample identified to be reactive for the presence of HIV-1 p24 antigen and absent of antibodies to HIV (p24 antigen positive). Ortho's investigation confirmed this issue and identified five additional lots of Vitros HIV combo reagent pack that also generated false negative results when tested using the same hiv-1 p24 positive sample. For this scenario, to date, Ortho's investigation has shown that this issue is limited only to Hiv-1 p24 antigen detection and does not affect the antibody detection of antihiv-1 or anti-hiv-2 in Vitros Hiv combo reagent pack.

Scenario 2:
During the investigation in scenario 1, Ortho received complaints related to repeat reactive results for Vitros Hiv combo reagent pack. Ortho confirmed that known negative samples could produce reactive results. Ortho's data demonstrates a correlation to the same lots implicated in scenario 1.

Recall start date: August 30, 2022

Additional information

Original published date:
Alert / recall type
Health product recall
Health products - Medical devices - Haematology

Ortho-Clinical Diagnostics

Felindre Meadows, Bridgend, Great Britain, CF35 5PZ

Published by
Health Canada
General public
Recall class
Type II
Identification number

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