{ "companyId": "50626", "slug": "hologic-inc-50626", "name": "Hologic, Inc.", "clearances": { "total": 116, "last12Months": 3, "first": "1987-10-08", "latest": "2026-06-17" }, "medianReviewDays": 87, "productCodeCount": 33, "recalls": { "total": 63, "openLast12Months": 6, "recent": [ { "resNumber": "Z-2167-2026", "productCode": "MUE", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2026-04-08", "reason": "Complaints have been received of systems developing loose, missing, or broken internal bolts over time." }, { "resNumber": "Z-2168-2026", "productCode": "OTE", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2026-04-08", "reason": "Complaints have been received of systems developing loose, missing, or broken internal bolts over time." }, { "resNumber": "Z-1949-2026", "productCode": "QYV", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2026-03-23", "reason": "It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual." }, { "resNumber": "Z-1586-2026", "productCode": "OYB", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2026-02-18", "reason": "Due to product exhibiting potential to generate either invalid or false negative results." }, { "resNumber": "Z-1314-2026", "productCode": "KNW", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-12-15", "reason": "Presence of particulates in affected devices that can be deposited into breast tissue during use." } ] }, "registration": { "sites": 5, "countries": [ "US" ] }, "productCodes": [ { "code": "KGI", "deviceName": "Densitometer, Bone", "clearances": 29, "latest": "2013-05-31", "medianReviewDays": 113 }, { "code": "HIH", "deviceName": "Hysteroscope (And Accessories)", "clearances": 13, "latest": "2019-08-29", "medianReviewDays": 52 }, { 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"Sterilization Wrap Containers, Trays, Cassettes & Other Accessories", "clearances": 3, "latest": "2019-02-26", "medianReviewDays": 210 }, { "code": "KNW", "deviceName": "Instrument, Biopsy", "clearances": 3, "latest": "2018-04-10", "medianReviewDays": 148 }, { "code": "PQA", "deviceName": "Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System", "clearances": 3, "latest": "2024-11-25", "medianReviewDays": 79 }, { "code": "QOF", "deviceName": "Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents", "clearances": 3, "latest": "2024-11-15", "medianReviewDays": 87 }, { "code": "HIG", "deviceName": "Insufflator, Hysteroscopic", "clearances": 2, "latest": "2024-07-25", "medianReviewDays": 115 }, { "code": "JAA", "deviceName": "System, X-Ray, Fluoroscopic, Image-Intensified", "clearances": 2, "latest": "2005-05-13", "medianReviewDays": 21 }, { "code": "LSL", "deviceName": "Dna-Reagents, Neisseria", "clearances": 2, "latest": "2024-01-26", "medianReviewDays": 90 }, { "code": "MWP", "deviceName": "Cabinet, X-Ray System", "clearances": 2, "latest": "2019-01-10", "medianReviewDays": 79 }, { "code": "OMM", "deviceName": "Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr", "clearances": 2, "latest": "2011-05-13", "medianReviewDays": 399 }, { "code": "OOU", "deviceName": "Parainfluenza Multiplex Nucleic Acid Assay", "clearances": 2, "latest": "2017-10-23", "medianReviewDays": 33 }, { "code": "PCH", "deviceName": "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System", "clearances": 2, "latest": "2025-09-25", "medianReviewDays": 90 }, { "code": "GEI", "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories", "clearances": 1, "latest": "2026-06-17", "medianReviewDays": 210 }, { "code": "KPR", "deviceName": "System, X-Ray, Stationary", "clearances": 1, "latest": "1991-10-30", "medianReviewDays": 70 }, { "code": "MKZ", "deviceName": "Dna Probe, Nucleic Acid 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"deviceName": "Panther Fusion GI Bacterial Assay", "productCode": "PCH", "decisionDate": "2025-09-25", "reviewDays": 99 }, { "kNumber": "K243341", "deviceName": "Genius AI Detection 2.0", "productCode": "QDQ", "decisionDate": "2025-07-31", "reviewDays": 279 }, { "kNumber": "K243396", "deviceName": "Aptima SARS-CoV-2 Assay", "productCode": "QQX", "decisionDate": "2025-02-13", "reviewDays": 105 }, { "kNumber": "K243935", "deviceName": "Aptima CMV Quant Assay", "productCode": "PAB", "decisionDate": "2025-01-17", "reviewDays": 28 }, { "kNumber": "K243345", "deviceName": "Aptima BV Assay; Aptima CV/TV Assay", "productCode": "PQA", "decisionDate": "2024-11-25", "reviewDays": 28 }, { "kNumber": "K242465", "deviceName": "Panther Fusion SARS-CoV-2/Flu A/B/RSV assay", "productCode": "QOF", "decisionDate": "2024-11-15", "reviewDays": 87 }, { "kNumber": "K240886", "deviceName": "Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) 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{ "name": "Hologic, Inc.", "dataset": "device/510k", "method": "normalised" }, { "name": "Hologic, Inc.", "dataset": "device/registrationlisting", "method": "normalised" } ] }, "sources": { "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Hologic%2C%20Inc.%22", "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Hologic%2C%20Inc.%22" }, "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51 }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2 }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53 }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:58:22Z", "ingestRun": 74 }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52 }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10 } ], "retrievedAt": "2026-08-11T14:48:53.039Z" }