{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215775", "product_res_number": "Z-0571-2026", "event_date_initiated": "2025-08-19", "event_date_posted": "2025-11-19", "recall_status": "Open, Classified", "res_event_number": "97499", "product_code": "JKA", "k_numbers": [ "K081929", "K983952" ], "product_description": "Brand Name: Vacuette\nProduct Name: 8 ml CAT Serum Separator Clot Activator\nModel/Catalog Number: 455071P\nProduct Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)", "code_info": "Lot Code: Lot/Serial Numbers: Item# 455071P Lot# B250437N\nUDI-DI code: 29120017573061", "firm_fei_number": "3001451379", "recalling_firm": "Greiner Bio-One North America, Inc.", "address_1": "4238 Capital Dr", "city": "Monroe", "state": "NC", "postal_code": "28110-7681", "additional_info_contact": "704-261-7800", "reason_for_recall": "Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.", "root_cause_description": "Labeling Change Control", "action": "On 08/22/2025, the firm sent via email an \"Urgent Medical Device Correction\" letter to customer informing them that some Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator which may affect the stability of the sample.\n\nCustomers are instructed to:\n\" Stop use immediately: Discontinue use of the affected product (concerned Item/Lot)\nand isolate it within your facility.\n\" Notify staff and customers: Inform all relevant employees and notify all customers to\nwhom you distributed the affected products.\n\" Assess risk: Evaluate potential risks or consequences in accordance with your internal\nprocedures and take appropriate action.\n\" Confirm product disposition: Complete the attached Product Disposition Site\nConfirmation Form and return it via fax to 877-217-7927 or email to recalls.us@gbo.com.\nConfirmation is required that all affected products have been discarded/destroyed.\nReplacement products will be provided upon receipt of your completed form.\n\nFor questions, call Greiner Bio-One Technical Service at 800-515-8112.", "product_quantity": "1,980,000", "distribution_pattern": "U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY.\n\nO.U.S.: None", "openfda": { "k_number": [ "K021941", "K900856", "K213718", "K922445", "K983490", "K023075", "K223810", "K222141", "K945777", "K013971", "K933401", "K201237", "K201009", "K063852", "K791303", "K960858", "K971111", "K953994", "K222299", "K802211", "K945353", "K030076", "K202325", "K244047", "K830472", "K200027", "K230408", "K160657", "K232781", "K884111", "K191832", "K890109", "K011699", "K120490", "K220900", "K810664", "K921520", "K926253", "K181895", "K231237", 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