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    Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

    FDA Recall
    Terminated ·Cepheid·Product code OPU·February 19, 2010

    Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA. Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative detection and differentiation of 2009 H1N1 influenza viral RNA.

    FDA Recall
    Terminated ·Cepheid·Product code OPU·February 19, 2010

    QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 1, 2015

    QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets include: 1. 0864E3 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 1, 2015

    Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA. Medical device, qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aures DNA directly from patient positive blood cultures. It is not intended to monitor treatment for MRSA/SA infections. Sub culturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing.

    FDA Recall
    Terminated ·Cepheid·Product code NQX·April 5, 2010

    Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;

    FDA Recall
    Terminated ·Cepheid·Product code NQX·November 17, 2011

    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089

    FDA Recall
    Terminated ·Cepheid·Product code NJR·September 5, 2007

    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique

    FDA Recall
    Open, Classified ·Cepheid·Product code NQX·August 6, 2025

    Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48

    FDA Recall
    Terminated ·Cepheid·Product code NJR·April 1, 2011

    Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use

    FDA Recall
    Terminated ·Microbiologics Inc·Product code PMN·January 31, 2019

    Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.

    FDA Recall
    Terminated ·Cepheid·Product code LSL·July 27, 2015

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Cepheid Xpert C. difficile/Epi Control Panel

    FDA Recall
    Open, Classified ·Microbiologics Inc·Product code PMN·May 16, 2019

    Cepheid, Sample Collection Device, Part: 900-0370

    FDA Recall
    Open, Classified ·Cepheid·Product code JSM·June 20, 2024

    SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler

    FDA Recall
    Terminated ·Cepheid·Product code NSR·July 22, 2005

    Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.

    FDA Recall
    Terminated ·Cepheid·Product code LSL·October 9, 2017

    Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization

    FDA Recall
    Terminated ·Cepheid·Product code NQX·July 18, 2016

    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only

    FDA Recall
    Open, Classified ·Cepheid·Product code PGX·April 24, 2023

    Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

    FDA Recall
    Open, Classified ·Cepheid·Product code PEU·November 5, 2025