{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210290", "product_res_number": "Z-0259-2025", "event_date_initiated": "2024-08-23", "event_date_posted": "2024-10-30", "recall_status": "Open, Classified", "res_event_number": "95439", "product_code": "JHI", "k_numbers": [ "K944426" ], "product_description": "Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy.\nModel/Catalog Number: 1004", "code_info": "UDI-DI: 00742860100208\n\nLot Number: 563L13", "firm_fei_number": "2246703", "recalling_firm": "Princeton Biomeditech Corp", "address_1": "4242 US Highway 1", "city": "Monmouth Junction", "state": "NJ", "postal_code": "08852-1905", "additional_info_contact": "SAME\n732-274-1000", "reason_for_recall": "This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.", "root_cause_description": "Process change control", "action": "PBM notified the Distributor Sekisui Diagnostics on 8/23/24 via email. The sent an \"URGENT PRODUCT RECALL NOTICE\" dated 8/30/24 to customers. Sekisui Diagnostics issued a recall notice on 9/6/24 to its customers. \n\nPBM Letter states reason for recall, health risk and action to take:\nStop distribution or use of OSOM Ultra hCG Combo Test lot 563L13.\n\" If you have further distributed this product, please identify your customers, and notify\nthem at once of this product recall. This recall should be carried out to the user level.\nYour notification to your customers may be enhanced by including a copy of this recall\nnotification letter.\n\" Quarantine and return any kits from the listed lots, (1) currently in your inventory,\nand (2) returned from your customers.\n\" Indicate the quantity returned on the attached CONFIRMATION OF NOTIFICATION\nform, and follow the instructions to complete, even if you do not have any affected\nproduct remaining in your inventory.\nComplete, sign and return the CONFIRMATION OF NOTIFICATION form to the email\nprovided by the date indicated on the form.\n\nPlease note replacement product equivalent to the quantity of products you returned from the affected lot will be processed once the CONFIRMATION OF NOTIFICATION form has been received.\n\nIf you have any questions, call PBM Technical Services at Tel 1-732-274-1000 or E-mail\n.", "product_quantity": "1,860 kits (50,220 test devices)", "distribution_pattern": "US Distribution 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"Visual, Pregnancy Hcg, Prescription Use", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1155", "device_class": "2" } } ] }