{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "151383", "product_res_number": "Z-0902-2017", "event_date_initiated": "2016-12-01", "event_date_posted": "2016-12-23", "recall_status": "Terminated", "event_date_terminated": "2017-05-01", "res_event_number": "75817", "product_code": "JQP", "product_description": "Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0\nSpecimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports", "code_info": "Software Version 1.0", "firm_fei_number": "3006159931", "recalling_firm": "PerkinElmer Health Sciences, Inc.", "address_1": "940 Winter St", "city": "Waltham", "state": "MA", "postal_code": "02451-1457", "additional_info_contact": "781-663-6900", "reason_for_recall": "Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.", "root_cause_description": "Software design", "action": "PerkinElmer Health Sciences issued a Medical Device Correction letter dated December 1, 2016, to all affected customers email facilitated through our PerkinElmer Software Services group located in Akron Ohio. Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures.\nActions to be taken\nA field correction of the issue is recommended. PerkinElmer will correct the issue with an update installed through remote connection. You will be contacted by your PerkinElmer representative to make the necessary arrangements for implementing the update.\nIn the interim period, please do not attempt to login multiple times in quick succession. Allow the software time to respond to first login command.\nPlease contact your local PerkinElmer representative or Specimen Gate Support for further information.\nOther Information\nPlease inform those affected in your organization accordingly.\nTo comply with regulatory requirements we request that you complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 22, 2016.\nFor questions regarding this recall call 781-663-6900.", "product_quantity": "21", "distribution_pattern": "Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru", "openfda": { "k_number": [ "K861412", "K802251", "K801091", "K800241", "K821531", "K810968", "K802594", "K800282", "K810063", "K893838", "K983468", "K854265", "K790543", "K801131", 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"medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.2100", "device_class": "1" } } ] }