{ "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": "176664", "product_res_number": "Z-0268-2020", "event_date_initiated": "2019-09-10", "event_date_created": "2019-11-01", "recall_status": "Terminated", "event_date_terminated": "2020-11-13", "res_event_number": "83879", "product_code": "CGZ", "k_numbers": [ "K071801" ], "product_description": "VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.", "code_info": "400506564305 400506564331 400506565287 400506575299 400506575361 400506635353 400506758400 400506728360 400506788811 400506758797 400506758798 400506789422 400506789423 400506809507 400506809508 400506820116 400506895392 400506895393 400506895394", "firm_fei_number": "1000305840", "recalling_firm": "Ortho-Clinical Diagnostics", "address_1": "513 Technology Blvd", "city": "Rochester", "state": "NY", "postal_code": "14626-3601", "additional_info_contact": "Ortho Care Technical Solutions\n585-453-4224", "reason_for_recall": "Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.", "root_cause_description": "Process control", "action": "On September 10, 2019, the firm distributed Urgent Product Correction Notification letters to affected customers. Customers were asked to take the following actions:\n\n\"Complete and return the Confirmation of Receipt form.\n\"If you experience a slide dispense issue, try to reposition the ABP by following the instructions in the enclosed Resolving Slide Dispense Issues document. Please place the instructions by each VITROS System in your facility that processes Microslides.\n\"If you are unable to reposition the ABP, remove the affected cartridge and replace it with a new one. Complete and return the Request for Credit form as needed to receive credit for the slides remaining within affected and discarded cartridges. \n\"Please forward this notification if the product was distributed outside of your facility.\n\nThe firm will provide credit for the slides remaining within affected cartridge for which you are unable to reposition the ABP.\n\nIf you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.", "product_quantity": "1365545 total", "distribution_pattern": "Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.", "openfda": { "k_number": [ "K973742", "K020148", "K962479", "K963734", "K790653", "K972004", "K844021", "K900887", "K860668", "K863395", "K953860", "K070531", "K861669", "K182072", "K953862", "K935228", "K912561", "K912647", "K980757", "K060108", "K000926", "K981270", "K013451", "K885193", "K893628", "K991870", "K003664", "K070889", "K170320", "K963992", "K003668", "K993697", "K052027", "K924864", "K162020", "K980367", "K953861", "K082099" ], "device_name": "Electrode, Ion-Specific, Chloride", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1170", "device_class": "2", "registration_number": [ "", "1000256526", "9610633", "8030478", "2250051", "1220649", "1319809", "2245578", "3003637681", "2050012", "3004493545", "1616487", "3013513377", "3010324880", "9614698", "2221819", "1219029", "3002807968", "1317202", "9610126", "3007490412", "1717966", "1219913", "2030861", "3003593973", "8020888", "3003030793", "2431530", "2247288", "3009473156", "3000126629", "1000455123", "3006198300", "1220972", "3004959793", "3023268435", "1319681", "3002809144", "3008244372", "3005643513", "9614673", "1827821", "3000148879", "2517506", "3005509212", "3037000637", "8020316", "3003795116", "3009156722", "1222035", "3002637618", "3010825766", "2432235", "3007662974", "9612296", "9610816", "3016244760", "3011989923", "3004102403", "3004438098", "2050010", "3016438761", "1000414342", "1217183", "1036223", "3023162659", "3014607865", "1036362", "3004378326", "3005333358", "1319436", "3007603826", "1181121", "3012817228", "2085064", "9610529", "3014506106", "3003971136" ], "fei_number": [ "", "1000256526", "2250051", "1220649", "2245578", "3003637681", "3003559576", "3002808382", "2050012", "3004493545", "1616487", "3013513377", "3010324880", "1000305840", "2221819", "1219029", "3002806560", "3002807968", "1317202", "3007490412", "1717966", "3002806559", "1219913", "3003593973", "3003030793", "2431530", "3009473156", "3000126629", "1000455123", "3006198300", "1000122044", "1000135102", "1220972", "3004959793", "3023268435", "1000120319", "3002809144", "3008244372", "3005643513", "3002806809", "3002806693", "1827821", "3000148879", "2517506", "3005509212", "3037000637", "3003795116", "3009156722", "1222035", "3002637618", "3010825766", "3007019572", "2432235", "3007662974", "3002807167", "3016244760", "3002807663", "3011989923", "3001576181", "3004102403", "3004438098", "2050010", "3016438761", "1000414342", "1217183", "1036223", "3023162659", "3014607865", "1036362", "1000136573", "3000215862", "3004378326", "3005333358", "3007603826", "1181121", "3012817228", "3014506106", "3003971136" ] } } ] }