UW recalls test kits with quality control issue

On April 17, 2020, the Washington State Department of Health was alerted by UW Medicine to discontinue use of a recently-procured batch of COVID-19 specimen collection kits that UW Medicine believed may have a quality control issue. 

As a result, last night DOH recalled approximately 12,000 kits sent to local health jurisdictions, tribal nations, and state agency partners across the state.

“Though the quality control issue has only been observed in a small number of tubes of viral transport media, we adhere to the highest quality standards for COVID-19 testing in Washington state,” said Secretary of Health John Wiesman. “We are working with our partners to have them discard the product and will work to replace them as quickly as we can.”

Viral transport media (VTM) is the fluid that preserves a specimen during transport, such as one collected via nasal swab from a person being tested for COVID-19. Some of the vials of VTM were an unusual color, which prompted UW Medicine to reach out to DOH to work together to investigate potential contamination. DOH officials believe there is no health risk to patients, as the VTM does not come in contact with patients during a COVID-19 test.

Testing completed today at UW Medicine has indicated that the quality issues observed in the small number of the VTM tubes did not impact COVID-19 test results. While this investigation is still ongoing, DOH is choosing to recall both the VTM and the nasal collection swabs out of an abundance of caution.

The recalled specimen collection kits were procured by UW Medicine and donated to DOH from Lingen Precision Medical Products. No other supplies previously used for testing are impacted by this recall. Jurisdictions who received these kits are encouraged to contact DOH for a new shipment of swabs and VTM transport tubes for replacement. DOH and state supplies aren’t adequate at the moment to immediately replace all swabs and VTM transport tubes, however, a large shipment of swabs from another vendor is expected this week and the state has VTM from another vendor.

The state is working closely with both the UW Medicine and local health partners to replace the recalled specimen collection kits as quickly as possible.