Recall Z-1594-2023

Reason for recall

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

FDA-determined cause: Material/Component Contamination

Action taken

Press release issued 5/4/23 by SD BioSensor: https://www.prnewswire.com/news-releases/recall-notice---sd-biosensor-inc-requests-discontinuation-of-use-and-disposal-of-specific-pilot-covid-19-at-home-tests-in-the-united-states-due-to-microbial-contamination-in-the-liquid-buffer-solution-301816494.html A notification letter titled "Subject: Statement about the patient risk assessment for the Extraction buffer of Pilot" COVID-19 At-Home Test" dated 3/31/23 was sent to Roche. A Roche URGENT MEDICAL DEVICE REMOVAL notification letter dated 5/4/23 was sent to customers. . Assess your current inventory, quarantine, and discontinue distribution of all affected PilotTM COVID-19 At-Home Test kits, and Roche will contact you in the near future to discuss final actions related to the affected product in your inventory. . If you distributed product to consumers, make information in the enclosed Pilot COVID-19 At-Home Test Consumer Message (TP-01837) available to your consumers per your established process for recall notification. . Complete all sections of the enclosed Recall Response form (TP-01836) and return it according to the instructions on the form. . Maintain this Urgent Medical Device Removal (UMDR) for future reference. In addition to this communication to U.S. distributors, as part of a media release on May 03, 2023, consumers are being asked to stop using and discard affected test kits, and contact Roche directly for follow-up actions. Questions Product images, lot information, and consumer actions are available at go.roche.com/pilottest or by contacting the Roche Support Network Customer Support Center at 1-866-987-6243 and select option 1.