Recall Z-1594-2023 ยท QKP Coronavirus Antigen Detection Test System.
SD Biosensor, Inc.
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
| Date | May 23, 2023 (initiated Mar 31, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Material/Component Contamination |
| Action | 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 inv |
| Quantity | 2,712,767 kits |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.