Health Canada has restricted the use of a recently approved test for COVID-19 to research purposes only, leading to a recall.
In a Sunday (May 3) email, Health Canada said it’s placed conditions of Spartan Biosciences’s authorization to restrict the use of the portable test until “adequate evidence of clinical performance can be provided.”
The test, which promised to provide results in under an hour and eliminated the need to travel to a lab, was approved on April 13. Ontario, Alberta, Quebec and the federal government had already ordered the tests. B.C. was not among the provinces that ordered the Ottawa-based company’s test.
Spartan Bioscience said it as voluntarily recalling its test and performing additional studies.
Spartan said Health Canada was concerned about the “efficacy of the proprietary swab” for the testing product. The company says Health Canada had no concerns about the accuracy and analytical performance of the product.
On Sunday, chief medical officer Dr. Theresa Tam said this highlighted the importance of quality assurance.
“It was in the real life setting that it didn’t perform well,” Tam said, noting the recall did not affect any patient diagnoses.