{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "99799", "product_res_number": "Z-2571-2011", "event_date_initiated": "2011-04-07", "event_date_posted": "2011-06-16", "recall_status": "Terminated", "event_date_terminated": "2012-02-19", "res_event_number": "58657", "product_code": "JFP", "k_numbers": [ "K043218", "K914166", "K954612", "K962334", "K974818", "K980130" ], "product_description": "Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105, ABL600, ABL700 Series, and ABL800 Analyzers. The membranes are packaged in a plastic box which contains four (4) membranes per box. \n\nCalcium membrane jackets that are used in the ABL505/555, EML105, ABL600, ABL700 Series and ABL800 Analyzers for InVitro testing of samples of whole blood for the parameters pH, PO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, CCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions: FO2Hb, FCOHb, FMetHb, FHHb andFHbF).", "code_info": "Part Numbers:  942-046, all lot numbers between 319 and 325  942-060, all lot numbers between 159 and 252", "firm_fei_number": "1523456", "recalling_firm": "Radiometer America Inc", "address_1": "810 Sharon Dr", "city": "Westlake", "state": "OH", "postal_code": "44145", "additional_info_contact": "440-871-8900 Ext. 209", "reason_for_recall": "Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used", "root_cause_description": "Pending", "action": "The firm, Radiometer America, sent a \"MEDICAL DEVICE FIELD CORRECTION\" letter dated April 14, 2011, to all affected customers. The letter describes the product, problem and the actions to be taken. \n\nThe letter provides the customers with a series of steps to be taken when replacing the Calcium Membrane (Until further notice the above procedure must be carried out when replacing the Calcium membrane). The letter also provides quality control instructions for verifying calcium performance. Additionally, the customer is required to manually adjust the upper and lower QC limits on the analyzer in relation to the limits printed on the insert sheet in order to detect the bias during quality control measurements (This must be done for every lot of QC ampoules used, and for any new lot of ampoules installed).\n\nThe letter asks that each customer complete and return the attached form via fax to 440-871-0463, in order to verify that the notification letter was received. \n\nQuestions should be directed to the firm's Technical Support staff at 800-736-0600, Opt. 4.", "product_quantity": "30323 boxes", "distribution_pattern": "Worldwide Distribution--USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV, and the countries of: Algir, argentina, Austria, Austrailia, Bahrain, Belarus, Belgium, Brazil, Brunei Darussalam, China, Columbia, Cuba, Greece, Denmark, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greenland, Guatemala, Hungary, India, Iraq, Ireland, Isreal, Italy, Jamaica, Japan, Kasakhstan, Kenya, Lebanon, Lithuania Korea, Malaysia, Malta, mexico, Moldavia, Nepal, New Zealand, Norway, Netherlands, Peru, Philipines, Poland, Portugal, Qatar, Oman, Rumania, Russia, Saudi Arabia, Singapore, Serbia and Kosvo, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Syria, Thailand, The Netherlands, Tunesia, Turkey, UK, Ukraine, United Arabia Emirates, Urguary, Usbekistan, and Venezuela.", "openfda": { "device_name": "Electrode, Ion Specific, Calcium", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1145", "device_class": "2", "k_number": [ "K896316", "K830502", "K844188", "K960120", "K230300", "K801848", "K972673", "K191360", "K934642", "K802856", "K860639", "K943702", "K915675", "K943091", "K873345", "K895397", "K771643", "K984299", "K152327", "K961458", "K810203", "K884771", "K880973", "K963694", "K823389", "K191626", "K830213", "K884731", "K904726" ], "registration_number": [ "3000126629", "1219029", "3003030793", "3003971136", "3004102403", "3011989923", "2050012", "3007490412", "9680746", "3006198300", "3003795116", "1217183", "3012817228", "2050010", "9610126", "3002807968", "2432235", "2245578", "3013513377", "3005643513", "3002637618", "1220649", "1219913", "3037000637", "2030861", "9610816", "9610633", "3023162659", "1220972", "1181121", "2431530", "3014506106", "3004959793" ], "fei_number": [ "3000126629", "1219029", "3003030793", "3002806693", "3003971136", "3002806559", "3004102403", "3011989923", "2050012", "3007490412", "3006198300", "3003795116", "1217183", "3012817228", "2050010", "3002807968", "2432235", "2245578", "3013513377", "3005643513", "3002637618", "1220649", "1219913", "3037000637", "1000206808", "3002807167", "3023162659", "1220972", "3000215862", "1181121", "2431530", "3014506106", "3004959793" ] } } ] }