BEUDAMED
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    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    FDA Recall
    Open, Classified ·Life Technologies Corporation·Product code PFF·February 7, 2024

    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

    FDA Recall
    Open, Classified ·Oxoid Australia Pty Limited 20 Dlgleish St South Australia Australia·Product code LQL·March 3, 2026

    Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

    FDA Recall
    Open, Classified ·Oxoid Limited Wade Road Basingstoke United Kingdom·Product code JTN·December 23, 2024

    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

    FDA Recall
    Open, Classified ·Microgenics Corporation·Product code JJY·October 1, 2025

    Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JWY·May 1, 2025

    remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSI·February 13, 2025

    remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSI·February 13, 2025

    Blood/MacConkey Biplate 100/PK, Product Number R02049

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSI·July 11, 2025

    Blood/EMB, Levine 100/PK, Product Number R02041

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSI·July 11, 2025

    Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSH·July 11, 2025

    Strep Selective II Agar, Product Number R01859

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSI·July 11, 2025

    Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.

    FDA Recall
    Open, Classified ·The Binding Site Group, Ltd.·Product code OTA·April 16, 2026

    QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3

    FDA Recall
    Open, Classified ·Microgenics Corporation·Product code MLM·January 20, 2022

    remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

    FDA Recall
    Open, Classified ·Remel, Inc·Product code JSD·August 14, 2023

    Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.

    FDA Recall
    Open, Classified ·Remel Inc·Product code JSO·March 10, 2021

    Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.

    FDA Recall
    Open, Classified ·Remel Inc·Product code JSO·March 10, 2021