{ "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": 1 } }, "results": [ { "cfres_id": "196063", "product_res_number": "Z-0080-2023", "event_date_initiated": "2022-09-02", "event_date_posted": "2022-10-12", "recall_status": "Open, Classified", "res_event_number": "90852", "product_code": "QKP", "product_description": "Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002", "code_info": "Lots: \nCC-10094-A,\nCC-10115-A,\nCC-10123-A,\nCC-10129-A,\nCC-10136-A,\nCC-10144-A,\nCC-10148-A,\nCC-10166-A,\nCC-10168-A,\nCC-10168-B,\nCC-10189-A,\nCC-10193-A,\nCC-10300-A,\nCC-10328-A,\nCC-10329-A,\nCC-10330-A,\nCC-10361-A,\nCC-10364-A,\nCC-10365-A,\nCC-10368-A,\nCC-10369-A,\nCC-10395-A,\nCC-10396-A,\nCC-10397-A,\nCC-10398-A,\nCC-10399-A,\nCC-10439-A,\nCC-10440-A,\nCC-10440-B,\nCC-10441-A,\nCC-10441-B,\nCC-10609-A,\nCC-10609-B,\nCC-10611-A,\nCC-10613-A,\nCC-10615-A,\nCC-10654-A,\nCC-10667-A,\nCC-10710-A,\nCC-10710-B,\nCC-10712-A,\nCC-10714-A,\nCC-10714-B,\nCC-10725-A,\nCC-10727-A,\nCC-10729-A,\nCC-10766-A,\nCC-10768-A,\nCC-10809-S,\nCC-10811-S,\nCC-10874-A,\nCC-10874-B,\nCC-10874-C,\nCC-50002-S,\nCC-50003-S,\nCC-50004-S\nExpiration Dates: expiry.clipcovid.com", "firm_fei_number": "3015104453", "recalling_firm": "LUMINOSTICS, INC dba CLIP HEALTH", "address_1": "46430 Fremont Blvd", "city": "Fremont", "state": "CA", "postal_code": "94538-6469", "reason_for_recall": "COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.", "root_cause_description": "Incorrect or no expiration date", "action": "On 09/02/2022, Field Safety notices were emailed to customers who were asked to do the following: 1) Locate affected devices in inventory and go to expiry.clipcovid.com to determine the expiration date. 2) Acknowledge receipt and understanding of the notice by emailing sales@cliphealth.com. 3) Share this notice with all those who need to be aware within your organization, or to any organization where the subject devices have been transferred. 4) If you are a distributor, please send proof to Clip Health by September\n16th, of your notification to your customers, and their response. Questions or concerns can be emailed to sales@cliphealth.com\n\nOn 09/21/2022, an updated field safety correction notice was sent to customers. In addition to the information above, customers were asked to do the following:\na) Product beyond expiry, as shown on expiry.clipcovid.com, should be quarantined. b) Check this website periodically for potentially extended expiration dates. c) Ensure products are within expiration date claims before use. d) Acknowledge receipt and understanding of the notice using the link provided on the notice.", "product_quantity": "10037 boxes of 25", "distribution_pattern": "US nationwide distribution", "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" } } ] }