EPA (Environmental Protection Agency)
1 records
fda
33 records
FDA Recall: Hologic, Inc — Class II
20260520
Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | Product: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3...
View Source
FDA Recall: Hologic, Inc — Class II
20260506
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the | Product: Brand Name: Genius" Review Station Pr...
View Source
FDA Device Recall: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Numb
2026-03-25
Class II — Due to product exhibiting potential to generate either invalid or false negative results.
View Source
FDA Device Recall: ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
2026-01-21
Class II — Fungal contamination of affected lot with Parengyodontium album.
View Source
FDA Recall: Hologic, Inc. — Class II
20250122
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of tre | Product: Panther Fusion GBS Assay REF PRD-04484...
View Source
FDA Device Recall: The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rap
2025-02-12
Class II — Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffe...
View Source
FDA Device Recall: Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent
2025-01-22
Class II — Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
View Source
FDA Device Recall: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
2025-01-01
Class II — SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
View Source
FDA Recall: Hologic, Inc — Class II
20241218
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set | Product: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Su...
View Source
FDA Recall: Hologic, Inc — Class I
20240515
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, dis | Product: BioZorb Marker-BioZorb 3D Bioabsorbabl...
View Source
FDA Device Recall: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Sur
2024-12-18
Class II — IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
View Source
FDA Device Recall: BioZorb Marker. Radiographic soft tissue marker.
2024-12-04
Class I — Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
View Source
FDA Device Recall: BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking
2024-05-15
Class I — Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from fee...
View Source
FDA Device Recall: PANTHER FUSION System REF 9121010000 The Panther System is an integrated nu
2024-01-31
Class II — Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
View Source
FDA Device Recall: Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D
2023-03-01
Class II — C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
View Source
FDA Device Recall: The BioZorb LP Marker is an implantable radiopaque marker used to facilitate vis
2022-10-12
Class II — Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date ...
View Source
FDA Device Recall: Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vit
2022-04-13
Class II — Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
View Source
FDA Device Recall: Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting
2020-06-03
Class II — Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in fals...
View Source
FDA Device Recall: Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimension
2020-03-04
Class II — The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
View Source
FDA Device Recall: Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
2018-02-28
Class II — Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material ...
View Source
FDA Device Recall: Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The P
2018-02-21
Class II — The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
View Source
FDA Recall: Hologic, Inc — Class II
20170809
A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incor | Product: Tomcat Instrument, REF ASY-07379, Holo...
View Source
FDA Device Recall: Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vi
2017-10-25
Class II — An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
View Source
FDA Device Recall: Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sam
2017-08-09
Class II — A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
View Source
FDA Recall: Hologic, Inc — Class II
20160504
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of | Product: Hologic InPlex CF Molecular Test (IVD)...
View Source
FDA Device Recall: SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-
2016-09-14
Class II — Tip Breakage at the glue joint between the obturator body and tip
View Source
FDA Device Recall: SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-
2016-09-14
Class II — Tip Breakage at the glue joint between the obturator body and tip
View Source
FDA Device Recall: Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
2016-05-04
Class II — Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
View Source
FDA Device Recall: NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Control
2014-03-05
Class II — NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
View Source
FDA Device Recall: Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is
2013-05-22
Class II — The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.
View Source
FDA Recall: Hologic, Inc. — Class II
20121003
Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, vers | Product: Hologic Fluoroscan Mini C-Arm Model wi...
View Source
FDA Device Recall: Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5
2012-10-03
Class II — Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stor...
View Source
FDA Device Recall: Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.
2012-10-03
Class II — InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ ...
View Source
ftc
1 records
ftc_enforcement
2 records
Hologic Inc., In the Matter of
2006-08-09
FTC live enforcement action FY2006; matched respondent 'Hologic Inc., In the Matter of'
View Source
Hologic, Inc. / Fischer Imaging
2006-07-07
FTC merger enforcement action FY2006 matter 510263; matched respondent 'Hologic, Inc.'
View Source
lobbying
5 records
Lobbying Client: HOLOGIC, INC.
Lobbied by ARNOLD & PORTER KAYE SCHOLER LLP — A leading women's health medical device manufacturer
View Source
ny_corps
1 records
NY Corp: HOLOGIC, INC.
2017-06-28
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
View Source
SEC EDGAR
1 records
sec_efts
1 records
SEC Filing: HOLOGIC INC
2026-01-26
SEC EDGAR filing — Forms: 8-K — Query: proxy statement
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.