BEUDAMED
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    Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ILH·August 18, 2023

    BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended for use as an aid in diagnosis of CDAD.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code LLH·March 5, 2010

    Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LLH·September 23, 2003

    ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LLH·June 2, 2006

    BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections.

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

    Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

    FDA Recall
    Terminated ·Remel Inc·Product code LLH·August 20, 2012

    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B 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.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code LLH·October 11, 2013

    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.

    FDA Recall
    Terminated ·Remel Inc·Product code LLH·August 20, 2012

    Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

    FDA Recall
    Terminated ·Sekisui Diagnostics LLC·Product code LLH·September 16, 2013

    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JLH·May 10, 2021

    BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 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 fr.om 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

    VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code LLH·September 22, 2021

    Gas Chromatography, Alcohol

    FDA classification
    FDA Class 2 ·Gas Chromatography, Alcohol

    Washer Of Body Waste Receptacles

    FDA classification
    FDA Class 1 ·Washer Of Body Waste Receptacles

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    Test, Luteinizing Hormone (Lh), Over The Counter

    FDA classification
    FDA Class 1 ·Test, Luteinizing Hormone (Lh), Over The Counter

    25-Oh-Vitamin D Mass Spectrometry Test System

    FDA classification
    FDA Class 2 ·25-Oh-Vitamin D Mass Spectrometry Test System

    TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

    FDA Recall
    Terminated ·Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom·Product code MWI·March 25, 2011

    React Health PHOENIX 5L Oxygen Concentrator

    FDA Recall
    Open, Classified ·3B Medical, Inc. 5475 Rings Rd Ste 550 Dublin OH 43017-7537·Product code CAW·February 4, 2026