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    CareLink Clinic, REF: MMT-7350

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code PHV·October 21, 2025

    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code PHV·August 5, 2016

    Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OYB·February 18, 2026

    KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas HPV Test include the following liquid based collection media and collection device: " ThinPrep Pap TestTM PreservCyt Solution " Endocervical Brush/Spatula

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code MAQ·July 25, 2013

    AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·March 10, 2004

    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code MBB·February 11, 2015

    HPV Antigen Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code MAQ·November 3, 2025

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code OHQ·January 20, 2025

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code OHQ·January 20, 2025

    SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·July 20, 2011

    AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·March 10, 2004

    Hybrid Capture 2 High-Risk HPV DNA Test, Catalog # 5101-1296

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MAQ·September 12, 2024

    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code MAQ·August 2, 2018

    Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only.

    FDA Recall
    Terminated ·Digene Corp·Product code MAQ·February 7, 2003

    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code JJQ·January 12, 2011

    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495

    FDA Recall
    Open, Classified ·Kreatech Biotechnology Bv Vlierweg 20 Amsterdam Netherlands·Product code MVU·November 1, 2024

    BD COR System Software. Model Number: 444829.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code MAQ·June 23, 2025

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 27, 2014