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    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

    FDA Recall
    Terminated ·Diagnostic Hybrids Inc·Product code LKA·December 31, 2012

    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code CEW·October 26, 2016

    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code N/A·November 3, 2015

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code CIN·July 14, 2016

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·April 4, 2017

    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·November 3, 2015

    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

    FDA Recall
    Terminated ·Diagnostic Hybrids Inc·Product code JZH·October 16, 2014

    Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass culture tubes 16x125mm, with screw caps. The product is distributed in EPS shipping racks which can hold up to 50 tubes each. Used routinely for in vitro diagnostic testing for virus and/or Chlamydia isolation and to aid in the diagnosis of diseases associated with infectious agents.

    FDA Recall
    Terminated ·Diagnostic Hybrids Inc·Product code KIR·January 21, 2009

    MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code OTR·November 3, 2015

    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

    FDA Recall
    Open, Classified ·Conavi Medical Inc.·Product code OBJ·March 12, 2025

    Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications.

    FDA Recall
    Terminated ·Biogenex Laboratories·Product code KEY·January 23, 2009

    ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA

    FDA Recall
    Terminated ·Vysis·Product code MMW·February 19, 2004

    BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code LLH·May 22, 2012

    Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument; The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the Roche Confidential Page 3 of 9 LightCycler Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.tributed by Roche Diagnostics Indianapolis, IN 46256 USA; 03610195001

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JPF·March 31, 2011

    Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001. For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code NPQ·March 31, 2011

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·December 22, 2006

    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OZN·October 10, 2013

    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OZN·October 16, 2013

    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