{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "199496", "product_res_number": "Z-1555-2023", "event_date_initiated": "2023-03-10", "event_date_posted": "2023-05-04", "recall_status": "Open, Classified", "res_event_number": "92055", "product_code": "JJE", "k_numbers": [ "K182063" ], "product_description": "VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products \nMicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products\nReagents\nProduct Code: 6844461", "code_info": "UDI: 10758750031610\nSerial Number Range: J76000109- J76001492", "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": "SAME\n908-218-8776", "reason_for_recall": "MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable", "root_cause_description": "Under Investigation by firm", "action": "Ortho Clinical issued Important Product Correction letter on 3/10/23 to customers with VITROS XT7600 & 5600 Integrated Systems (CL2023-061) and instructed:\nUntil further notice, Ortho recommends loosening and then retightening all caps for MicroTip reagents or diluents immediately prior to loading them onto the system. Per the V-Docs/Maintenance Troubleshooting Guide instructions, Manual MicroTip Reagent Pack Cap Removal, Chapter 6 Troubleshooting, Remove reagent pack caps manually if they become too tight for the MICROTIP PACK OPENER to uncap. The purpose of executing this procedure is to loosen the caps without removing them, and then manually tighten the caps.\n For VITROS 5600: J33044 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal.\nFor VITROS XT7600 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal\n\n\" Complete the enclosed Confirmation of Receipt form no later than March 24, 2023.\n\" Please forward this notification if the affected product was distributed outside of your facility.\n\" Save this notification with your user documentation or post this notification by each VITROS 5600 or XT 7600 System until root cause investigation is completed.\n\" If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care\" Technical Solutions Center. Contact Information\nOrtho Care Technical Solutions Center at 1-800-421-3311", "product_quantity": "2001 units", "distribution_pattern": "Nationwide including Puerto Rico and Bermuda\nForeign:\nAustralia\nBelgium\nBrazil\nCanada \nChile\nChina\nColombia\nDenmark\nFrance\nGermany\nIndia\nItaly\nJapan\nMexico\nNorway\nPortugal\nRussia\nSingapore\nSpain\nSweden\nThe Netherlands\nUnited Kingdom", "openfda": { "k_number": [ "K961481", "K833116", "K823386", "K831649", "K830318", "K885289", "K961274", "K801889", "K771245", "K842773", "K130915", "K863840", "K942922", "K802609", "K912024", "K813160", "K831518", "K872494", "K872103", "K945271", "K830762", "K893776", "K860748", "K872105", "K841076", "K904219", "K974779", "K922139", "K183375", "K915366", "K810596", "K962235", "K881498", "K890183", "K931786", "K760642", "K833448", "K922220", "K841916", "K870836", "K833067", "K922680", "K780464", "K950915", "K893547", "K810129", "K113253", "K040958", "K823762", "K873617", "K811919", "K971761", 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