{ "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": 21 } }, "results": [ { "cfres_id": "119039", "product_res_number": "Z-0537-2014", "event_date_initiated": "2013-05-02", "event_date_posted": "2013-12-18", "recall_status": "Terminated", "event_date_terminated": "2014-03-12", "res_event_number": "65476", "product_code": "JTO", "k_numbers": [ "K842828" ], "product_description": "Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England.\n\nStreptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.", "code_info": "Lot 1192181, exp. January 2014", "firm_fei_number": "1924669", "recalling_firm": "Remel Inc", "address_1": "12076 Santa Fe Trail Dr", "city": "Lenexa", "state": "KS", "postal_code": "66215-3519", "additional_info_contact": "Earleen C. Parks\n913-888-0939", "reason_for_recall": "The product may give weak or false negative test results.", "root_cause_description": "Process control", "action": "ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).\nFor questions regarding this recall call 913-888-0939.", "product_quantity": "768 kits", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K812047", "K926254", "K870409", "K920971", "K902640", "K802496", "K955826", "K840029", "K840252", "K831674", "K834581", "K905472", "K834028", "K834029", "K843987", "K840896", "K840483", "K790038", "K840578", "K813509", "K920257", "K860396", "K811854", "K925747", "K932752", "K913011", "K820264", "K812084", "K896398", "K862570", "K870410", "K831187", "K833901", "K834389", "K801493", "K830323", "K954812", "K861259", "K863216", "K940124", "K831654", "K833654", "K840708", "K820212", "K902037", "K913010", "K833407", "K863601", "K840579", "K844020", "K820207", "K823718", "K840575", "K873509", "K802127", "K761209", "K822946", "K926256", "K841270", "K860091", "K970834", "K913007", "K770926", "K840028", "K880950", "K830099", "K902595", "K930693", "K913003", "K830968", "K844086", "K840804", "K860560", "K813031", "K812083", "K840884", "K830756", "K821992", "K962966", "K844380", "K970832", "K840031", "K852886", "K861889", "K933514", "K821040", "K861058", "K870422", "K852666", "K841329", "K842587", "K871907", "K923700", "K801916", "K841262", "K812458", "K802566", "K960996", "K842086", "K820206", "K870561", "K913001", "K970833", "K844382", "K801915", "K811853", "K820204", "K781567", "K812082", "K844383", "K844276", "K840686", "K841453", "K831673", "K861888", "K926255", "K840614", "K913006", "K860563", "K931413", "K923827", "K951889", "K813613", "K882636", "K905163", "K934125", "K802500", "K860564", "K901784", "K844887", "K940020", "K860565", "K901390", "K812859", "K905666", "K945881", "K802502", "K864244", "K913008", "K860562", "K930878", "K820210", "K802509", "K934986", "K860301", "K961191", "K820213", "K830939", "K940162", "K840819", "K931862", "K930718", "K860561", "K840810", "K953247", "K801492", "K931414", "K854448", "K820211", "K851184", "K871445", "K810541", "K934129", "K812862", "K813610", "K894221", "K941111", "K950346", "K936034", "K833963", "K945883", "K945882", "K844381", "K970009", "K874933", "K941016", "K802501", "K905151", "K811998", "K912480", "K860302", "K832306", "K873034", "K934130", "K802497", "K841508", "K954783", "K841460", "K813442", "K880694", "K820209", "K841277", "K870717", "K840577", "K840584", "K843316", "K821907", "K940161", "K840030", "K840576", "K843521", "K852889", "K840582", "K945880", "K921583", "K840581", "K823738", "K930720", "K913002", "K844019", "K832436", "K840508", "K832307", "K832305", "K931865", "K920972", "K920973", "K834022", "K913009", "K834269", "K852832", "K870449", "K823198", "K882630", "K801951", "K812877", "K936021", "K050352", "K890625", "K930717", "K800579", "K840580", "K870716", "K820205", "K782086", "K800816", "K842828", "K822930", "K860156", "K913004", "K841479", "K813612", "K832587", "K840583" ], "registration_number": [ "9615755", "8020667", "3006897996", "8010096", "1924669", "2016672", "3023191945", "9615754", "3006440892", "2247035", "3003750284", "3043126851", "1210083", "2916932", "3024171133", "8010383", "3009307598", "2022807", "2242239", "3013490757", "2647876", "1119779", "3009171251", "3013160357", "3016741564", "9610649", "3006091463" ], "fei_number": [ "3006897996", "4247", "1924669", "3023191945", "3006440892", "3003750284", "1000122268", "3043126851", "1210083", "3008237827", "2916932", "3006759904", "3024171133", "3002807578", "3009307598", "2022807", "2242239", "1000220444", "3013490757", "2647876", "3007808629", "1119779", "3006224287", "1000354384", "3013160357", "3016741564", "3006091463" ], "device_name": "Discs, Strips And Reagents, Microorganism Differentiation", "medical_specialty_description": "Microbiology", "regulation_number": "866.2660", "device_class": "1" } } ] }