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Vitros immunodiagnostic products hiv combo reagent pack
Official notice
14 Sept 2022
Last checked
14 Sept 2022
An official Health Canada notice concerns Vitros immunodiagnostic products hiv combo reagent pack. 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 Published 2022-09-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64548
Official notice
2022-09-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Ortho-clinical Diagnostics, Vitros Immunodiagnostic Hiv Combo Reagent Pack.
Source & status
Source & status
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Tier
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Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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