May 03, 2020
By Jeremy Logan
Ottawa’s Spartan Bioscience says it is voluntarily recalling its COVID-19 product and performing additional studies after Health Canada expressed some concerns Friday.
Spartan says 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.
Health Canada says the product is restricted to research use only until adequate evidence of clinical performance can be provided.
The federal government announced it had approved the hand-held DNA analyzer on April 13th.
The need for greater testing is widely acknowledged as key to understanding the true scope of COVID-19 infection in Canada, and how best to deploy suppression strategies.