BEUDAMED
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    Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

    FDA Recall
    Open, Classified ·AGILENT TECHNOLOGIES INC./US·Product code PQP·February 17, 2023

    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·December 4, 2017

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·February 15, 2023

    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·February 8, 2018

    FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·November 8, 2022

    Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

    FDA Recall
    Open, Classified ·CARIS LIFE SCIENCES·Product code PQP·June 17, 2025

    Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 20, 2026

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·April 9, 2025

    FoundationOne CDx (F1CDx), RAL-0003 version 31.0

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·November 8, 2022

    FoundationOne Companion Diagnostic (F1CDx)

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·June 18, 2024

    FoundationOne CDx test report

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·August 8, 2019

    Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code PQP·March 16, 2020

    FoundationOne CDx Test Results

    FDA Recall
    Terminated ·Foundation Medicine, Inc.·Product code PQP·October 31, 2018

    Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.

    FDA Recall
    Open, Classified ·Foundation Medicine, Inc.·Product code PQP·March 24, 2026

    Seattle PAP Plus, MP02260

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZD·April 17, 2023

    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JFH·March 5, 2018

    FISHER SCIENTIFIC Aseptic Control LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code MMS·May 25, 2022