HIV tests used at Montreal hospitals recalled after suspect results noticed

The McGill University Health Centre (MUHC) has identified approximately 9,000 patients who may have received false negatives through recalled HIV tests, but the health centre maintains the risk of error is extremely low.

Any possible suspect results would have been returned to patients sometime over a 10-month period. The patient samples were collected at several hospitals and clinics, including at Lasalle Hospital, and were then analyzed by laboratories located at St-Mary's and Lakeshore Hospitals.

The laboratories in question that conducted the analyses are overseen by Optilab Montreal-MUHC. The MUHC was unable to provide a complete list of clinics, hospitals or doctor's offices where samples may have been taken before they were sent to the labs.

However, a spokesperson at the MUHC explained in a series of emails what occurred. Between December 2021 and September 2022, around 9,000 HIV tests were analyzed using a chemical reagent that was recalled by the manufacturer on Sept. 2, 2022.

According to the MUHC, Ortho Clinical Diagnostics, the company that makes the tests, discovered a problem with the reagent when another laboratory in Canada reported a discrepancy after conducting a routine evaluation.

The recalled tests had been distributed to clinical laboratories across Quebec and Canada, including ones managed by Optilab-MUHC.

"There was a problem with one of the components in 2 batches of the test distributed in Canada," according to a statement from MUHC spokesperson Sandrine Pelletier.

Pelletier went on to say that means, "it was theoretically possible 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."

"The component of the test that detects established infection (ie. antibodies against HIV) was not affected," she said.

'I'M FURIOUS'

Among the 9,000 patients who were affected was one woman who contacted CTV News.

"I'm furious. I'm absolutely livid about this whole thing. Thank God I'm all right, but there are 8,999 other people walking around who may or may not have HIV, and that's concerning," said the woman, whom CTV has agreed not to identify for privacy reasons.

Following the recall, the MUHC said it notified Quebec's health ministry, but neither organization publicly announced the news.

Instead, the MUHC said it sent letters to the patient's doctors.

A doctor whose clinic l'Actuel specializes in the treatment and prevention of HIV described that reaction as unacceptable and said he was unaware of the recall until he was contacted by CTV News.

"For me, it's completely insufficient, unethical for a disease as severe as HIV is," said Dr. Rejean Thomas.

The long-time HIV expert said even if the risk of a false-negative was extremely low, it should have been communicated to the general public.

"It's a very severe diagnosis. To have a false-negative, that could be possible on 9,000 if you only have one or two or three, it's a serious affair," he said.

"You could infect many other persons believing that you are HIV negative."

The woman who first contacted CTV said she was never informed about the issue by her family doctor but did receive a letter in the mail from the MUHC in early December, a full three months after the recall.

The letter explained the risk of an incorrect result was low, but she was encouraged to get retested.

"Thank God that it came back negative the second time," she said, "but I doubt very much that they have been able to reach all 9,000 people before and during the holidays to warn them."

HIV support worker Emelie Renahy also called the delay unacceptable.

"It's not okay to know things and not to reach out to people right away to let them know there is an issue, this is a health concern for the person directly but for others as well. So, it's a public health issue," said Renahy, who works at AIDS Community Care Montreal.

The Quebec Ministry of Health told CTV News that some samples have yielded false negatives.

"According to the information provided by the supplier, this situation has been reported very rarely by all users of these kits. The offending batches are no longer in use and the supplier has put measures in place to ensure that the problem is corrected," said spokesperson Marjorie Larouche.