{ "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": "112213", "product_res_number": "Z-0045-2013", "event_date_initiated": "2012-08-10", "event_date_posted": "2012-10-10", "recall_status": "Terminated", "event_date_terminated": "2012-12-17", "res_event_number": "62968", "product_code": "JIT", "product_description": "IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles.\nThe IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.", "code_info": "Lot 975, EXP Sep 2012", "firm_fei_number": "3002485711", "recalling_firm": "Immunodiagnostics Systems Ltd", "address_1": "10 Didcot Way Bolden Business Park", "city": "Boldon Tyne & Wear", "country": "United Kingdom", "reason_for_recall": "It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.", "root_cause_description": "Labeling False and Misleading", "action": "Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer:\n\nCustomers should complete the attached Recall and Acknowledgement Form and take the following actions:\n\n1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately.\n\n2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return.\n\n3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office.\nContact information was also provided.\nFor questions regarding this recall call +44 (191) 5195212.", "product_quantity": "29", "distribution_pattern": "Nationwide Distribution including NY, CA, ME and CT.", "openfda": { "k_number": [ "K142181", "K093357", "K061751", "K823023", "K163534", "K843112", "K872263", "K895649", "K913371", "K053291", "K994291", "K792290", "K991705", "K800220", "K061702", "K760349", "K823020", "K033786", "K871764", "K823019", "K061818", "K823025", "K981101", "K143342", "K082141", "K121027", "K170938", "K170160", "K052982", "K021607", "K020980", "K904698", "K032285", "K130698", "K072717", "K854784", "K842099", "K141728", "K833702", "K823022", "K851670", "K871768", "K061885", "K781072", "K052193", "K061139", 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