{ "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": "160143", "product_res_number": "Z-0605-2018", "event_date_initiated": "2017-08-24", "event_date_created": "2018-02-13", "recall_status": "Terminated", "event_date_terminated": "2020-08-28", "res_event_number": "78699", "product_code": "JIX", "k_numbers": [ "K043460" ], "product_description": "Lyophilized Chemistry Calibrator Level 1 \n\nProduct Usage:\nBeckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.", "code_info": "Lots # 6101K51 and 6101K61", "firm_fei_number": "2050012", "recalling_firm": "Beckman Coulter Inc.", "address_1": "250 S Kraemer Blvd", "city": "Brea", "state": "CA", "postal_code": "92821-6232", "additional_info_contact": "Customer Support\n800-854-3633", "reason_for_recall": "Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.", "root_cause_description": "Under Investigation by firm", "action": "On August 28, 2017 a letter was sent to all the customers stating the following:\nAttention Beckman Coulter Customer,\nBeckman Coulter is initiating a field action for the product listed above. This letter contains important information that needs your immediate attention.\nISSUE:\n Unpaired lots of AU Lyophilized Chemistry Calibrator level 1 and 2 have been distributed.\n Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination.\n Paired calibrator lots are identified by the last two digits of the lot number.\nCalibrator Level 1 REF DR0070-1, Lot 6101K51\nCalibrator Level 2 REF DR0070-2, Lot 6102K61\nIncorrect pair\nCalibrator Level 1 REF DR0070-1, Lot 6101K61\nCalibrator Level 2 REF DR0070-2, Lot 6102K61\nCorrect pair\nIMPACT:\n If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results.\n QC failures could occur if incorrect pairs of calibrators are used.\nCalibrator Level 1 REF DR0070-1, Lot 6101K51\nCalibrator Level 2 REF DR0070-2, Lot 6102K61\nIncorrect pair\n If the above incorrect pair is run with Level 1 lot 6101K51and Level 2 lot 6102K51 set points, erroneous results could be generated for the following assays:\no Bicarbonate : maximum 11% bias low\no Calcium Arsenazo : maximum 5% bias low\no Calcium oCPC : maximum 5% bias low\no Inorganic Phosphorous : 6.4% bias high\no Magnesium: 3.2% bias low\n If the above incorrect pair is run with Level 1 lot 6101K61 and Level 2 lot 6102K61 set points, erroneous results could be generated for the following assays:\no Bicarbonate : maximum 15.8% bias high\no Direct Bilirubin OSR6x181: 8.7% bias low\n\nACTION: Check the level 1 and level 2 calibrators to make sure you are using\ncorrectly paired lots for calibration.\n Ensure correct set points are being used for the lot. Set points are in\nthe IFU for each lot and can be found in each kit, or on the Beckman\nCoulter websites", "product_quantity": "unknown", "distribution_pattern": "Worldwide Distribution in the states of AL, AK, AZ, AK, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IO, KS, KY, LA, MA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VI, WA, WV, WI, and WY\nand the countries of Brazil, Canada, Costa Rica, El Salvador, Guam, Paraguay, and Peru", "openfda": { "k_number": [ "K101460", "K841456", "K984014", "K930199", "K897071", "K770142", "K110251", "K800040", "K963533", "K023268", "K030169", "K810964", "K960103", "K873116", "K061390", "K934701", "K030621", "K024305", "K874587", "K871638", "K000576", "K823044", "K871341", "K061750", "K840278", "K984425", "K964527", "K981305", "K904767", "K855014", "K023158", "K051457", "K791956", "K851151", "K042551", "K850405", "K060940", "K033501", "K041905", "K844344", "K881258", "K864909", "K861786", "K133330", 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