Recall Z-0124-2021 ยท QKP Coronavirus Antigen Detection Test System.
Quidel Corporation
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider wi
| Date | Sep 17, 2020 |
| Status | Terminated |
| Reason | Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended. |
| Root cause | Device Design |
| Action | On 09/17/20, "FIELD CORRECTIVE ACTION CORRECTION" notices dated 09/16/20 were emailed to customers. The firm called customers over the phone to convey the correction information to some customers. Customers were asked to take the following actions: 1) Discontinue the use of affected package inserts. 2) Access the updated instructions for use labeling which can be located by going to quidel.com/docs and selecting the Sofia SARS Antigen FIA Package Insert document. 3) In the event that your facility has used Remel viral transport media products (e.g., M4, M4RT, M6), please contact Quidel Techni |
| Quantity | 10537 |
| Distribution | U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.