{ "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": 1 } }, "results": [ { "cfres_id": "160121", "product_res_number": "Z-0265-2018", "event_date_initiated": "2017-04-13", "event_date_posted": "2017-12-19", "recall_status": "Terminated", "event_date_terminated": "2020-08-18", "res_event_number": "78688", "product_code": "JWY", "k_numbers": [ "K913459" ], "product_description": "ETEST OXACILLIN OX 256 WW F100 \n\nIn vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.", "code_info": "REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110.", "firm_fei_number": "1000611339", "recalling_firm": "BioMerieux SA", "address_1": "Chemin De L'Orme", "city": "Marcy L'Etoile", "country": "France", "additional_info_contact": "Jeff Scanlan\n314-731-8694", "reason_for_recall": "QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.", "root_cause_description": "Under Investigation by firm", "action": "BioMerieux sent an Urgent Field Safety Notice on April 30, 2017.\n\nShort-term Action: Subsidiaries and distributors are required to discard all ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.", "product_quantity": "1585 units", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.", "openfda": { "k_number": [ "K023202", "K992296", "K983027", "K883798", "K060621", "K192250", "K031205", "K230935", "K153569", "K001573", "K001036", "K945997", "K951879", "K250856", "K883555", "K874727", "K950328", "K882911", "K972180", "K861187", "K993679", "K974362", "K854099", "K181708", "K151873", "K894189", "K922003", "K042392", "K992059", "K944753", "K242905", "K062839", "K181889", "K922780", 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