{ "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": "185062", "product_res_number": "Z-0770-2021", "event_date_initiated": "2020-12-11", "event_date_posted": "2021-01-05", "recall_status": "Open, Classified", "res_event_number": "87028", "product_code": "JHS", "k_numbers": [ "K861387" ], "product_description": "VITROS Chemistry Products CKMB Slides:\n\n(1)VITROS CKMB Slides (60 Slide cartridge)\nProduct Code:8058232 \n\n(2)VITROS CKMB Slides (18 Slide cartridge)\nProduct Code: 8001133\n\nQuantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.", "code_info": "INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302)\nCoatings 0230, 0231, 0233, 0235, 0239 (all lot numbers)\n\nExtended Recalls: \nRecall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021\n\nRecall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication\nReference, CL2021-214) 18 August 2021\n\nRecall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication\nReference, CL2021-274) , 1 November 2021\n\nRecall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication\nReference, CL2023-244) , 27 October 2023\n\nUDI: \n(1) (10758750004294)\n(2) (10758750004201", "firm_fei_number": "2250051", "recalling_firm": "Ortho Clinical Diagnostics Inc", "address_1": "1001 US Highway 202", "city": "Raritan", "state": "NJ", "postal_code": "08869-1424", "additional_info_contact": "Ortho Care Technical Solutions\n800-421-3311", "reason_for_recall": "VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference", "root_cause_description": "Under Investigation by firm", "action": "Ortho Clinical Diagnostics (OCD) issued Urgent Product Correction Notification (CL2020-302) via ORTHO PLUSSM ( e-Communications, on 11 December 2020 to consignees. Letter states reason for recall, health risk and action to take:\n\nPer the VITROS CKMB Slides IFU, evaluate the Total CK value of the sample. For the respective CKMB coating, elevated total CK activity (>300 and <1000 U/L) may cause a significantly elevated VITROS CKMB Slides result. If the CK activity exceeds the value listed in the table on page 1, consult with your Medical Director.\n\" Depending on which coating is used in your laboratory, you may want to consider an alternate method for samples with CK activity greater than indicated in the table on page 1.\n\" If your laboratory chooses to discontinue using an affected coating, Ortho will credit your account. Current inventory levels do not allow for replacement. Provide credit quantity information using the Confirmation of Receipt form.\n\" Complete the enclosed Confirmation of Receipt form no later than 22-DEC-2020.\nNote: complete the form even if your laboratory no longer has inventory of affected product.\n\" Please forward this notification if the product was distributed outside of your facility.\n\nA VITROS CKMB Slides coating is currently being manufactured and is expected to be available in the first quarter of 2021. Ortho will continue to perform testing on all future coatings to evaluate CK-MM inhibition and will update the Technical Bulletin as appropriate.\n\n If you have further questions, please contact Ortho Care\" Technical Solutions Center at 1-800-421-3311.\n\nFirm issued Extended Recalls viasent via eComm, FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Dropship,\nDistributors and Federal Government):\n(1) Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication\nReference, CL2021-182) On 18 June 2021.\n(2) Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Comm", "product_quantity": "Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia,\tIndia, Japan, Mexico, Singapore 609917, United Kingdom, \tFrance, Germany, Italy, Spain, Portugal, Poland, Russia, \tDenmark, Norway, Sweden, Belgium, The Netherlands.", "openfda": { "k_number": [ "K160570", "K820722", "K790015", "K810997", "K801668", "K800028", "K082226", "K872029", "K062128", "K861387", "K790088", "K945083", "K802521", "K781690", "K823211", "K803169", "K792023", "K780504", "K952250", "K981495", "K790343", "K854708", "K990434", "K781432", "K855188", "K900806", "K883223", "K790917", "K843007", "K102706", "K941584", "K790918", "K790916", "K903025", "K962126", "K813406", "K943024", "K990439" ], "registration_number": [ "1219913", "9681753", "2432235", "1319681", "1319809", "2517506", "9610529", "9610126", "3003795116", "2250051", "3006198300" ], "fei_number": [ "1219913", "2432235", "3002806559", "1000136573", "2517506", "3000303338", "3003795116", "3002806560", "2250051", "1000305840", "3006198300" ], "device_name": "Differential Rate Kinetic Method, Cpk Or Isoenzymes", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1215", "device_class": "2" } } ] }