{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "221367", "product_res_number": "Z-2894-2026", "event_date_initiated": "2026-07-01", "event_date_posted": "2026-08-05", "recall_status": "Open, Classified", "res_event_number": "99344", "product_code": "JIT", "product_description": "5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905", "code_info": "UDI-DI: 05070002420378,\nLot Number: KE132603", "firm_fei_number": "3005017664", "recalling_firm": "Aniara Diagnostica LLC", "address_1": "7768 Service Center Dr", "city": "West Chester", "state": "OH", "postal_code": "45069-2442", "additional_info_contact": "Michele Washing\n513-505-5276", "reason_for_recall": "Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.", "root_cause_description": "Process control", "action": "Email notifications were sent to customers on 6/17/26. \n\nPlease reply to this email as acknowledgment you have received this initial notification and please include the quantity of each product which is remaining in your possession. \n\nA notification letter dated 7/1/26 was sent to customers.\n\nActions to be implemented:\n\" Destroy all stock of 5-PLASMA Bivalirudin Control, 5-PLASMA Bivalirudin Calibrator, & 5-PLASMA AMR Verification Kits\n- Please permanently deface the box labels and vial labels before disposal.\n\" Complete and return the Awareness Acknowledgement form.\n\" If product has been consumed please add brief statement to the Comment section, complete the End User Information, and return the Awareness Acknowledgement form.", "product_quantity": "4 units", "distribution_pattern": "US 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