{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189192", "product_res_number": "Z-0084-2022", "event_date_initiated": "2021-09-02", "event_date_created": "2021-10-08", "recall_status": "Terminated", "event_date_terminated": "2026-03-09", "res_event_number": "88658", "product_code": "OUG", "product_description": "MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System", "code_info": "MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2", "firm_fei_number": "3008237827", "recalling_firm": "BioMerieux SA", "address_1": "3 route de Port Michaud", "city": "La Balme les Grottes", "country": "France", "additional_info_contact": "+33 47495 7850", "reason_for_recall": "Under certain conditions, there is a risk for a false negative result.", "root_cause_description": "Software design", "action": "A customer letter was issued to impacted subsidiaries and distributors on 09/08/2021. The letter includes instructions that the customer verify that they operate under the specific conditions required for the anomaly to occur:\n\n\nYou are using MYLA (V4.7, V4.7.1, V4.8, V4.8.1 or V4.8.2) in conjunction with BCI Connect\nAND\nYou are managing Blood Culture analyses on BACT/ALERT VIRTUO connected to MYLA\nAND\nYour Blood Culture workflow is based on 2 or more bottles with the same specimen (same specimen/laboratory id)\nAND\nYou are using the LIS capability to send Blood Culture requests containing the incubation expected duration (MTT)\nAND\nYou are sending other requests than Blood Culture (Offline SU, ID,) on the same specimen than the one used for BC\nnote: this condition is applicable only if it occurs after the previous ones, chronologically speaking\n\n-\tIf the answer to ALL of the above questions is yes, then the customer must contact their bioMerieux representative for help to implement a workaround that should be used until MYLA version 4.9 is available. \nIf the answer to any of the above question is no, the customer will not be impacted by this anomaly. \n\nThe firm issued an updated Field Safety Corrective Action, FSCA #5308-2, on 9/29/2021 to subsidiaries and distributors which replaced FSCA #5308-1 to revise references in the FSCA document to only include the references of the impacted software. The firm added Annex I to the enclosed customer letter to be issued by the subsidiaries/distributors that provides guidance on how to check the MYLA software version and if BCI connectivity is being used.", "product_quantity": "542 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.", "openfda": { "k_number": [ "K122361" ], "device_name": "Medical Device Data System", "medical_specialty_description": "General Hospital", "regulation_number": "880.6310", "device_class": "1", "registration_number": [ "", "3004957206", "3005739655", "1066427", "3016053964", "3016499552", "3004070020", "3031823504", "3017829091", "3016670256", "3043041722", 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