{ "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": "196086", "product_res_number": "Z-0171-2023", "event_date_initiated": "2022-10-03", "event_date_posted": "2022-11-03", "recall_status": "Open, Classified", "res_event_number": "90866", "product_code": "GKZ", "k_numbers": [ "K090967" ], "product_description": "BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.", "code_info": "Added/Corrected as of 11/04/2022:\nCatalog Number: 340334\nUDI-DI Code: 00382903403349\nLot Numbers:\n2031144\n2034642\n2035110\n2035121\n2060660\n2073297\n2073298\n2095186\n2101458\n2108676\n2112862\n2152055\n2152064\n2152068\n2152075\n2152080\n2203024\n2208091\n2215812\n2235269\n2223229\n2236782\n2236934\n2236936\n2236937\n2236783\n2237006\n2237008\n2237012\n2237014\n2237015\n2237016", "firm_fei_number": "2916837", "recalling_firm": "Becton, Dickinson and Company, BD Biosciences", "address_1": "2350 Qume Dr", "city": "San Jose", "state": "CA", "postal_code": "95131-1812", "additional_info_contact": "Troy Kirkpatrick\n408-954-2100", "reason_for_recall": "Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. \nFirm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.", "root_cause_description": "Under Investigation by firm", "action": "On 10/03/2022, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\" Letter via FedEx tracked letters and emails informing customers, through internal investigations, the labels applied to the BD Trucount tubes are becoming detached due to an adhesive change made at a supplier.\n\nCustomers are instructed to:\n1. Immediately review their inventory for the specific catalog and lot numbers.\n2. For any tubes where label detachment is observed, BD recommends that the clinician remove the label from the tube and, using a permanent marker, record the tube lot number as well as any other relevant information directly on the tube. Removal of the label prevents it from interfering with any auto-loading sample preparation and analysis systems, as well as from sticking to other tubes.\n\nFor questions, contact North American Regional Complaint Center at:\nPhone: 1-844-8BD-LIFE (1-844-823-5433), Say \"Recall\" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com", "product_quantity": "52,570 tubes (corrected on 11/04/2022)", "distribution_pattern": "U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and WI\n\nO.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay", "openfda": { "k_number": [ "K960072", "K911626", "K160538", "K010765", 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