{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184955", "product_res_number": "Z-0800-2021", "event_date_initiated": "2020-11-20", "event_date_posted": "2021-01-07", "recall_status": "Terminated", "event_date_terminated": "2023-10-24", "res_event_number": "86972", "product_code": "JJE", "product_description": "enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).", "code_info": "enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using   Software Versions 4.6 and below", "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\n585-453-3000", "reason_for_recall": "A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.", "root_cause_description": "Software design", "action": "On November 20, 2020, the firm sent Urgent Product Correction Notification letters to affected customers to inform them of the issue. Customers were reminded to follow product labelling regarding removing all tubes before performing maintenance or initializing the Aliquoter & Labeller Module. There should never be sample tubes present when initializing the Aliquoter & Labeller module.\n\nThe firm's release of TCA Software version 4.7 is the planned mitigation for this issue.\n\nIf you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.", "product_quantity": "40 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.", "openfda": { "k_number": [ "K830212", "K854138", "K893547", "K884378", "K872494", "K843610", "K853003", "K945566", "K865105", "K950353", "K863531", "K870833", "K823762", "K902689", "K873749", "K841076", "K931786", "K042169", "K883533", "K882451", "K791297", "K841503", "K904219", "K971761", "K840129", "K950958", "K870836", "K840883", "K983345", "K874857", "K922680", "K040958", "K772319", "K792361", "K781528", 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