{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 15 } }, "results": [ { "cfres_id": "183267", "product_res_number": "Z-0124-2021", "event_date_initiated": "2020-09-17", "event_date_created": "2020-10-19", "recall_status": "Terminated", "event_date_terminated": "2022-08-09", "res_event_number": "86276", "product_code": "QKP", "product_description": "Sofia SARS Antigen FIA Package Insert\n\n 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 within the first five days of the onset of symptoms.", "code_info": "1438900EN00 (03/20) and 1438901EN00 (05/20)", "firm_fei_number": "2024674", "recalling_firm": "Quidel Corporation", "address_1": "10165 McKellar Ct", "city": "San Diego", "state": "CA", "postal_code": "92121-4201", "additional_info_contact": "858-552-1100 Ext. 7922", "reason_for_recall": "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_description": "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:\n1) Discontinue the use of affected package inserts.\n2) 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.\n3) In the event that your facility has used Remel viral transport media products (e.g., M4, M4RT, M6), please contact Quidel Technical Support to discuss your results.\n4) Confirm receipt of this notice by returning a signed copy to customernotifications@quidel.com\n\nPlease feel free to contact Technical Support at customernotifications@quidel.com or by calling 800.874.1517 (in the U.S.) with any questions or concerns that you may have regarding this issue.", "product_quantity": "10537", "distribution_pattern": "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.", "openfda": { "registration_number": [ "", "3008517993", "3014654360", "3016820006", "3017662853", "2431980", "3004142665", "3011522054", "3009014878", "3027500452", "3012516456", "2250051", "3016610313", "3039322300", "3012133212", "3020964039", "3008573045", "3016850770", "3003896222", "2246703", "3016837106", "3000308930", "3014660585", "3015883679", "3028746593", "3028107593", "3017887566", "3009238284", "3018187017", "2024674", "9610126", "1000115322", "1221359", "1122236", "3004181896", "3033507883", "1219913", "2020808", "3004146366", "3007111389", "3005984081", "3027518847", "3013160357", "3021082896", "3017171515", "3014862351", "3008925277", "1319681", "3023947183", "3002821211", "3033751096", "3017894300", "3020305857", "3032562", "3002642396", "3003297763", "3024756665", "2432235", "3016761091", "3039321686", "3002792284", "3026664926", "2032682", "3012963943", "3009963993", "2030538", "3008054239", "1313700", "3005360469", "2025099", "2029372", "3022474803", "9610240", "3043128348", "3011561946", "3026565854", "3023372670", "3021090658", "3008959428", "3025041446", "3008825965", "3014022295", "3010934853" ], "fei_number": [ "", "3008517993", "3014654360", "3016820006", "3017662853", "2431980", "3004142665", "3011522054", "3009014878", "3027500452", "3012516456", "2250051", "3016610313", "3039322300", "3012133212", "1000306617", "3020964039", "3008573045", "3016850770", "2246703", "3016837106", "3000308930", "3014660585", "3003952975", "3015883679", "3028746593", "3028107593", "3017887566", "3009238284", "3018187017", "2024674", "1000115322", "1221359", "1122236", "3004181896", "3002806559", "3010687142", "3033507883", "1219913", "2020808", "3004146366", "3007111389", "3005984081", "3002606748", "3027518847", "3013160357", "3021082896", "3017171515", "3014862351", "3005670738", "1000520007", "3023947183", "3002821211", "3033751096", "3017894300", "3020305857", "3002642396", "3003297763", "3024756665", "2432235", "3002808212", "3016761091", "3039321686", "3002792284", "3026664926", "3012963943", "3009963993", "3008054239", "1313700", "3022474803", "3007981058", "3043128348", "3011561946", "3026565854", "3023372670", "1000136573", "3004069780", "3021090658", "3008959428", "3025041446", "3008825965", "3014022295", "3010934853" ], "device_name": "Coronavirus Antigen Detection Test System.", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "N" } } ] }