{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192825", "product_res_number": "Z-1014-2022", "event_date_initiated": "2022-02-22", "event_date_posted": "2022-04-28", "recall_status": "Open, Classified", "res_event_number": "89894", "product_code": "GKP", "k_numbers": [ "K160276" ], "product_description": "ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:\nName Part Number \n1.ACL TOP 300 CTS 00000280060 \n2. ACL TOP 300 CTS 00000280060R (Refurbished)\n3. ACL TOP 350 CTS 00000280065 \n4. ACL TOP 500 CTS 00000280040 \n5. ACL TOP 500 CTS 00000280040R ( Refurbished)\n6/\n6. ACL TOP 550 CTS 00000280045 \n7. ACL TOP 970 CL 00000280097", "code_info": "All Serial Numbers.  Trade Name\t\t\t\tPart Number\t\t\t\t\t\tUDI\t\t\t\t\t ACL TOP 300 CTS\t\t\t\t00000280060\t\t\t\t\t08426950556916;\t\t\t\t\t \"ACL TOP 300 CTS (Refurbished)\"\t\t\t\t00000280060R\t\t\t\t08426950928027;\t\t\t\t\t ACL TOP 350 CTS\t\t\t\t00000280065\t\t\t\t\t08426950784081;\t\t\t\t\t ACL TOP 500 CTS\t\t\t\t00000280040\t\t\t\t\t08426950453499;\t\t\t\t\t \"ACL TOP 500 CTS (Refurbished)\"\t\t\t\t00000280040R\t\t\t\t\t08426950928003;\t\t\t\t\t ACL TOP 550 CTS\t\t\t\t00000280045\t\t\t\t\t\t08426950729242;\t\t\t\t\t ACL TOP 970 CL\t\t\t\t00000280097\t\t\t\t\t\t08430793045476.", "firm_fei_number": "1217183", "recalling_firm": "Instrumentation Laboratory", "address_1": "180 Hartwell Rd", "city": "Bedford", "state": "MA", "postal_code": "01730-2443", "additional_info_contact": "SAME\n781-861-4467", "reason_for_recall": "Updated and revised user instructions issued 7/14/22.\nPotential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine),\nspecific to instrument models that utilize a single reagent probe", "root_cause_description": "Under Investigation by firm", "action": "*****UPDATE******PHASE 2\nUPDATED - URGENT MEDICAL DEVICE CORRECTION \nThis updated notification is intended to further clarify the Mandatory Customer Actions for the potential carryover issue identified on the following ACL TOP systems (previous URGENT MEDICAL DEVICE CORRECTION letter dated Feb 22, 2022), when running a specific reagent combination.\nE-mail communication to the Werfen Affiliate and International Group circulated on July 14, 2022. Subsequent investigations have shown that the carryover issue only has the possibility of occurring if QFA Fibrinogen, Liquid Antithrombin, and Liquid Anti-Xa reagent aspirations occur in a specific sequence.\n\"\tBased on the above, we are revising the instruction to not run HemosIL Liquid Anti-Xa in the same batch as both HemosIL Liquid Antiithrombin and HemosIL Q.F.A. Thrombin (Bovine). \nPlease take one of the following immediate workflows to mitigate this potential carryover issue.\n\"\tRevised Instructions for Phase 2:\n1.\tUse Separate instruments to run Liquid Anti-Xa and Liquid Antithrombin.\n2.\tBatch Liquid Antithrombin.: Run Liquid Antithrombin tests in isolation (analyzer status starting and ending in a READY state).\n\n3.\tBatch Anti-Xa, Apixaban and Rivaroxaban testing. Run the maintenance activity Enhanced Clean for Reagent Probe or Enhanced Clean for All Probes from the maintenance menu, then run Liquid Anti-Xa (heparin), apixaban, and rivaroxaban tests in isolation (analyzer status starting and ending in a READY state).\nReturn the completed and signed Mandatory Response Tracking Form to:\n\" Fax No.: 1-781-861-4207 Or E-mail: ra-usa.na@werfen.com\nFor technical questions, please contact the Werfen Technical Support Center at 1-800-678-0710, Option # 1 (ACL Coagulation Products).\n\n\n\nPrevious: PHASE 1:\nWerfen issued Urgent Field Safety Notification via email /certified mail on 2/22/22. Letter states reason for recall, health risk and action to take:\nMandatory Customer Actions\nBased on the above, please take the following i", "product_quantity": "2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, S. Tome, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad, Tobago, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam.", "openfda": { "k_number": [ "K993174", "K921363", "K023362", "K073377", "K231031", "K961579", "K993299", "K943153", "K962664", "K881281", "K962857", "K992423", "K894052", "K063679", "K901120", "K884863", "K931992", "K150877", "K901380", "K001891", "K951072", "K001145", "K992321", "K942117", "K091980", "K964139", "K931206", "K921465", "K160276", "K933092", "K924098", "K914946", "K895844", "K954437", "K885035", "K031377", "K944227", "K991101", "K992763", "K904297", "K020979", "K033414", "K001645", "K981206", "K961991", "K813564", "K904204", "K931956", "K242127" ], "device_name": "Instrument, Coagulation, Automated", "medical_specialty_description": "Hematology", "regulation_number": "864.5400", "device_class": "2", "registration_number": [ "9613959", "3006198300", "8043723", "3002759288", "1644474", "3020704087", "1181121", "3010960914", "2245451", "3010421384", "3010362364", "3010188766", "1217183", "2432235", "3037000637", "3009711478", "9610806" ], "fei_number": [ "1000116989", "3006198300", "3002759288", "3002808301", "3020704087", "1181121", "3010960914", "2245451", "3001573851", "3010421384", "3010362364", "3010188766", "1217183", "2432235", "3037000637", "3009711478", "3001644026" ] } } ] }