Hologic Recalls
29 recalls on record in the United States
Hologic, Inc. recalls Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 0
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 from SDIX.
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Hologic, Inc. recalls Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 0
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 from SDIX.
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Hologic, Inc recalls Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 P
The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.
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Hologic, Inc. recalls Affirm Lateral Arm Upright Biopsy Accessory. Product Number:
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
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Hologic, Inc recalls Panther(R) System, Catalog Number 902615, For Use with Holog
An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.
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Hologic, Inc recalls Tomcat Instrument, REF ASY-07379, Hologic Incorporated, auto
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.
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Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biop
Presence of particulates in affected devices that can be deposited into breast tissue during use.
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Hologic, Inc recalls ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Fungal contamination of affected lot with Parengyodontium album.
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Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Bio
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
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Hologic, Inc. recalls The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a
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 buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN¿ for the TLiIQ¿ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.
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Hologic, Inc. recalls Panther Fusion GBS Assay REF PRD-04484 Kit containing Panthe
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
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Hologic, Inc. recalls Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.
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Hologic, Inc recalls Hologic Sizer Set- sterilization tray and 6 individual sizer
IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set
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Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
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Hologic Inc recalls Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis
Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis
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Hologic Inc recalls Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A,
Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.
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Hologic, Inc recalls BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
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Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-
Use of assay along with plasma specimen may result in error code which would invalidate sample.
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Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
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Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneo
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
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Hologic, Inc. recalls Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-000
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
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Hologic, Inc recalls The BioZorb LP Marker is an implantable radiopaque marker us
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 on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.
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Hologic, Inc recalls Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
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Hologic, Inc recalls Panther Fusion Extraction Reagent-X, REF PRD-04477, For use
Failed stability specifications for reagent kits that may result in false negative test results.
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Hologic, Inc recalls Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont.
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
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Hologic, Inc recalls Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.
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Hologic, Inc recalls Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE,
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 false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay in treatment.
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Hologic, Inc. recalls Selenia Dimensions Mammography System, Model number ASY-0416
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.
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Hologic, Inc. recalls I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
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