{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 7 } }, "results": [ { "cfres_id": "198718", "product_res_number": "Z-1295-2023", "event_date_initiated": "2023-02-21", "event_date_posted": "2023-03-29", "recall_status": "Open, Classified", "res_event_number": "91723", "product_code": "JJH", "product_description": "PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples", "code_info": "Lot number 3, Exp. 11/2023", "firm_fei_number": "3016994927", "recalling_firm": "Entopsis , Inc.", "address_1": "7600 Nw 69th Ave", "city": "Medley", "state": "FL", "postal_code": "33166-2521", "additional_info_contact": "Agustin Galecio\n888-407-5070", "reason_for_recall": "Presence of misleading label statements on the product label.", "root_cause_description": "Under Investigation by firm", "action": "The firm issued a MEDICAL DEVICE RECALL notice to its consignees on 02/21/22023 by email. Those without a valid email address were mailed the notice via certified mail. The notice explained the issue and risk and requested the customer/user take the following actions: \n\"Entopsis Inc., requests that the product lots listed below - shipped/received before\nFebruary 8st, 2023 be promptly discontinued from use and discarded from inventory as per your non-hazardous waste disposal plan.The labeling of PCRopsis products was revised on\nFebruary 8th, 2022. Updated statements of intended use and revised instructions for use are available on www.pcropsis.com. If you are currently using or intend to use the PCRopsis\nproduct lots affected by this recall please contact us at team@entopsis.net or 1-888-407-5070 (Monday to Friday 9.00 AM to 4.30 PM Eastern Time) to request a replacement. If you are a re-distributor of PCRopsis devices, notify your end customer with a copy of this letter. Please acknowledge the removal of affected product lots by filling out the attached acknowledgment form and returning it to us at team@entopsis.net.\nContact us at team@entopsis.net or 1-888-407-5070 - Monday to Friday 9.00 AM to 4.30 PM US Eastern Time (GMT -5) with any questions you may have.\"", "product_quantity": "3 units", "distribution_pattern": "Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania", "openfda": { "k_number": [ "K871290", "K960298", "K935496", "K833919", "K851393", "K930168", "K113731", "K941326", "K893733", "K770398", "K870690", "K760592", "K943965", "K801772", "K943966" ], "registration_number": [ "3009311010", "3020925311", "3007699074", "3013548521", "3019837962", "3004530258", "3002821232", "3006786907", "3027518847", "3026035655", "3002777243", "3003083993", "3018779125", "3003673482", "3007808978", "3045058049", "3011781554", "3009238284", "3014325803", "3020831613", "3009573214", "8020892", "3016837106", "3009443851", "3014290238", "3009155756", "3005271071", "3016764932", "3003402518", "3013540184", "3005248192", "1650733", "9615754", "1550222", "3005748564", "3009214950", "2915796", "3015529000", "3005118020", "9612003", "3013096769", "3018771894", "3017170972", "3004141078", "3017583200", "3015542780", "3004417597", "3028240331", "9615037", "3007054022", "3024647994", "3038622676", "3003335080", "3010031137", "9610529", "3016619649", "3004013603", "3010594620", "1224838", "3008937712", "3016998616", "3012494290", "8030996", "2134567", "3003795116", "3016764493", "3007143373", "8043909", "9610126", "3013756523", "8043379", "3012259842", "3007287152", "3016763307", "1119779", "3017434950", "3010030414", "2024800", "3016611336", "3016068451", "3016733849", "3014100717", "3021043070", "3016635427", "3005695808", "3008517993", "3010791816", "3021269066", "3009875001", "3017358793", "3017098905", "3009207631", "3012101172", "3028944399", "3007420875", "3006198300", "2030633", "2025606", "3015980628", "3013496958" ], "fei_number": [ "3009311010", "3020925311", "3007699074", "3013548521", "3019837962", "3004530258", "3002807666", "3002821232", "3006786907", "3027518847", "3026035655", "3002777243", "3003083993", "3002622561", "3018779125", "3003673482", "3007808978", "3045058049", "3011781554", "3009238284", "3014325803", "3020831613", "3009573214", "3009391812", "3016837106", "3009443851", "3014290238", "3009155756", "3005271071", "3016764932", "3003261083", "3003402518", "3013540184", "3005248192", "1550222", "3005748564", "1000513605", "3009214950", "2915796", "3015529000", "3013096769", "3018771894", "3017170972", "3004141078", "3017583200", "3015542780", "3004417597", "3028240331", "3002806560", "3007054022", "3024647994", "3038622676", "3003335080", "3010031137", "3016619649", "3004013603", "3010594620", "3008937712", "3016998616", "3012494290", "3003795116", "3016764493", "3007143373", "3013756523", "3003413192", "3002806559", "3012259842", "3007287152", "3016763307", "1119779", "3017434950", "3010030414", "3000210620", "2024800", "3016611336", "3016068451", "3016733849", "3014100717", "3021043070", "3001421318", "3016635427", "3005695808", "3002524000", "3008517993", "3010791816", "1000532580", "3021269066", "3009875001", "3017358793", "3017098905", "3009207631", "3002808498", "1318994", "3028944399", "3007420875", "3006198300", "3008237827", "2025606", "3015980628", "3013496958" ], "device_name": "Clinical Sample Concentrator", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2310", "device_class": "1" } } ] }