Recall issued for HIV check utilized in three Montreal hospitals

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A recall has been issued for an HIV test used in three Montreal hospitals over fears it could produce false negative results during the early phase of infection.

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As first reported by CTV Montreal, the recall was issued by manufacturer Ortho Clinical Diagnostics and could affect 9,000 patients who used the test at the Lakeshore, St. Mary’s and LaSalle hospitals.

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In an email response on Thursday, a spokesperson for the McGill University Health Center said Ortho Clinical Diagnostics discovered the issue when another laboratory noticed discrepancies during a routine evaluation.

“It is extremely unlikely that we will discover any false negative results, but at Optilab Montreal-CUSM, we decided to take no chances,” spokesperson Gilda Salomone wrote.

The health center immediately retested 3,000 samples it already had from previous tests with pregnant women, Salomone noted, which all came back negative and confirmed the initial result.

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The recall dates back to September, but patients received letters about it this month after doctors and nurses were advised to inform their patients. The MUHC also assigned three nurses to answer any questions from patients or doctors, Salomone added.

The issue with the test stems from a problem with one of the components in two batches that were distributed in Canada. The component of the test that detects antibodies against HIV was not affected, Salomone added.

“It was theoretically possible,” Salomone wrote, “that in rare circumstances, patients that were tested in a very early phase of HIV infection (ie, the first 2-3 weeks after infection) could obtain a false negative result.”

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