{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191724", "product_res_number": "Z-0665-2022", "event_date_initiated": "2022-01-06", "event_date_created": "2022-02-23", "recall_status": "Open, Classified", "res_event_number": "89486", "product_code": "JKA", "k_numbers": [ "K991088" ], "product_description": "BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes\nCatalog Number: 364902, 36490200", "code_info": "All Lots within Expiry\n\nCatalog No: 364902 UDI: (01)50382903649025\nCatalog Number: 36490200 UDI:(01)60382903649022", "firm_fei_number": "2243072", "recalling_firm": "Becton Dickinson & Company", "address_1": "1 Becton Dr", "city": "Franklin Lakes", "state": "NJ", "postal_code": "07417-1815", "additional_info_contact": "SAME\n201-847-6800", "reason_for_recall": "May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts", "root_cause_description": "Under Investigation by firm", "action": "BD issued Urgent Medical Device Correction letter via email to Sysmex on January 06, 2022, requesting they inform/distribute to their customers still using a Sysmex UF-1000i or UX-2000 analyzer the notification provided by BD .The scope would include any customers who were shipped Vacutainer LLAD products still using a Sysmex UF-1000i or UX-2000 analyzer.\nSysmex issued letter to their customers addressed to the Urinalysis Manager instructs the customer to respond to Sysmex. \n1. Sysmex customers should retain a copy of this notification and post near your analyzer as a visual reminder of this potential issue.\n2. Complete the Notification Response Form to confirm receipt of this medical device correction.\n3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.\n\n1. BD is updating the IFU for the LLAD products to include a precaution to confirm any\nabnormal urinalysis results per facility policy/procedure and best practices and that BD\nVacutainer LLAD devices are not recommended for use with Sysmex UF-1000i and UX-\n2000 analyzers as it may falsely identify contaminant particles as Red Blood Cells. BD\nwill notify Sysmex via follow-up communication when these revisions are completed\n(anticipated by June 2022).\n2. BD continues to investigate the root cause of this issue and will apply corrective actions as appropriate. Sysmex will be notified if any additional actions are required upon completion of the root cause analysis.\n\nProduct will continue to ship so as not to impact critical patient care.", "product_quantity": "288,152,790 Units", "distribution_pattern": "US Nationwide distribution in the state of IL.", "openfda": { "k_number": [ "K833475", "K893613", "K802209", "K252040", "K945777", "K230408", "K982999", "K980098", "K230391", "K962158", "K043143", "K944618", "K242320", "K231373", "K162233", "K122687", "K030394", "K252506", "K960860", "K060364", "K062932", "K981035", "K922342", "K791303", "K230855", "K022426", "K181895", "K231282", "K942240", "K223810", "K193569", "K926253", "K810816", "K000777", "K220900", "K940905", "K863491", "K864866", "K212019", "K931368", "K190604", "K030815", "K823176", "K831242", "K942241", "K923090", "K896206", "K960250", "K041071", "K991551", "K840496", "K945454", "K935588", "K945353", "K802211", "K181743", "K936240", "K991120", "K241586", "K081929", "K220258", 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