{ "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": 90 } }, "results": [ { "cfres_id": "202938", "product_res_number": "Z-0008-2024", "event_date_initiated": "2023-08-09", "event_date_posted": "2023-10-02", "recall_status": "Open, Classified", "res_event_number": "92927", "product_code": "JJE", "k_numbers": [ "K031924", "K081543", "K083173", "K182063" ], "product_description": "Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)", "code_info": "Assemblies with a date code between 040722 - 121922", "firm_fei_number": "1000136573", "recalling_firm": "Ortho-Clinical Diagnostics, Inc.", "address_1": "100 Indigo Creek Dr", "city": "Rochester", "state": "NY", "postal_code": "14626-5101", "additional_info_contact": "Mr. Joe Falvo\n585-453-3452", "reason_for_recall": "Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT PRODUCT CORRECTION NOTIFICATION dated 8/9/23 was sent to customers.\n\nTo determine if your laboratory is using an Assembly that was manufactured within the\naffected date range, check the date code stamped into the barrel of the Assembly. Refer to\nthe example image below to locate the date code on the barrel component of the Assembly.\nIf your laboratory has an Assembly with a date code between 040722 - 121922,\nthe Assembly is considered affected and must be replaced.\n\nREQUIRED ACTION\n\" Determine if any of the impacted VITROS Systems in your laboratory are using an affected Proboscis/Piston Assembly by checking the date code stamped into the barrel component. Once a replacement Proboscis/Piston Assembly is received, discard all affected Assemblies within the date range of 040722 - 121922.\n\" Determine if your inventory of VITROS spare parts contains any affected Proboscis/Piston Assemblies by checking the date code stamped into the barrel component. Once a replacement Proboscis/Piston Assembly is received, discard all affected Assemblies within the date range of 040722 - 121922.\n\" Ensure your laboratory is performing the Leak/Hysteresis test during daily maintenance and performing Quality Control to ensure a properly functioning Proboscis/Piston Assembly until a replacement Assembly is available.\n\" Complete the enclosed Confirmation of Receipt form no later than August 17, 2023. Upon receiving your completed Confirmation of Receipt form, QuidelOrtho will credit your account or send a replacement Proboscis/Piston Assembly (Part. No. J55375), if applicable.\n\" Post this notification by each VITROS 5,1 FS/3600/4600/5600/XT 3400/XT 7600 System until this issue is resolved.\n\" Please forward this notification if the affected product was distributed outside your facility.\n\nWe apologize for the inconvenience this will cause your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.", "product_quantity": "9,860 assemblies", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K130915", "K946090", "K833067", "K920402", "K904219", "K830212", "K945271", "K831477", "K843059", "K945135", "K790072", "K883209", "K073370", "K772319", "K910185", "K961481", "K830762", "K063144", "K040958", "K922139", "K800085", "K852133", "K832584", "K890184", "K843283", "K870833", "K893776", "K771245", "K840501", "K842500", "K811194", "K922680", "K782014", "K945566", "K853391", "K890927", "K841916", "K854243", "K771345", "K872105", "K962235", "K883533", "K781076", "K915366", "K854936", "K823386", "K840129", "K943493", "K942443", "K961274", "K842773", "K860748", "K792361", "K881498", "K883321", "K853621", "K950353", "K923579", "K940289", "K863840", "K051087", "K950958", "K810549", "K133519", "K840868", "K884378", "K833833", "K923060", "K885226", 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