The company behind a rapid coronavirus test that was expected to be massively rolled out in rural Alberta has voluntarily recalled its product.
Alberta Health Services had announced a partnership worth $9.5 million with Spartan Bioscience in late March.
The Ottawa-based Spartan said Sunday it is recalling its COVID-19 product and performing additional studies after Health Canada expressed some concerns.
AHS said that so far, it had only received a “small number” of the devices and had been testing the product before its planned rollout.
“We have not received the larger shipment that would be deployed across the province.”
Williamson said that the contract with Spartan has not been cancelled, but if the technology is not validated for clinical use, AHS would be reimbursed.
AHS will also be submitting its preliminary evaluation results to Health Canada, Williamson said.
The initial deal with Spartan called for AHS to receive handheld devices along with 100,000 testing kits to be distributed to facilities outside of Calgary and Edmonton.
Spartan said Health Canada was concerned about the “efficacy of the proprietary swab” for the testing product. The company said Health Canada had no concerns about the accuracy and analytical performance of the product.
It was initially approved for use in Canada on April 13.
Williamson said Sunday that Alberta’s testing capability “remains strong” and that the current demand for COVID-19 testing will still be met.
As of Saturday, AHS had conducted 157,517 COVID-19 tests in the province.
–With files from The Canadian PressView link »