{ "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": "91715", "product_res_number": "Z-0316-2011", "event_date_initiated": "2010-02-19", "event_date_posted": "2010-11-03", "recall_status": "Terminated", "event_date_terminated": "2011-05-18", "res_event_number": "55748", "product_code": "GKZ", "product_description": "BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA.\n\nThe intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.", "code_info": "Model/Catalog No. 647205. Manufacturing Lot/Serial # X0039; Sample Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769/Lot Nos. 92035 and 92036", "firm_fei_number": "2916837", "recalling_firm": "BD Biosciences, Systems & Reagents", "address_1": "2350 Qume Dr", "city": "San Jose", "state": "CA", "postal_code": "95131-1812", "additional_info_contact": "408-954-6307", "reason_for_recall": "Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. \nHaving a piece of the lid partially or fully clogging the Probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results.\nThe piece of the lid clogging the Probe can be in the processed sample tube. It has the", "root_cause_description": "Device Design", "action": "BD Biosciences sent an \"Important Product Information\" letter dated February 2010 and an \"URGENT: Follow-Up to Letter Dated February 2010\" letter dated July 2010 to customers identifying the affected device and actions to be taken: \nCustomers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers.\nCustomers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.", "product_quantity": "349 units", "distribution_pattern": "Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.", "openfda": { "k_number": [ "K960072", "K911626", "K160538", "K010765", "K021241", "K992849", "K942525", "K803219", "K091313", "K853304", "K922744", "K953498", "K162977", "K932530", "K030263", "K950918", "K844910", "K941171", "K030144", "K875346", "K945212", "K951459", "K871600", "K933475", "K982167", "K981568", "K961701", "K874147", "K936023", "K833600", "K090346", "K844645", "K945205", "K960887", "K953598", "K950742", "K953340", "K032039", "K060375", "K874427", "K052905", "K963263", "K993356", "K071141", "K922745", 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