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    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

    FDA Enforcement
    Class III ·Terminated·Microbiologics Inc·February 16, 2022

    KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·March 2, 2017

    The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code DSI·November 21, 2008

    Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    Allegiance Laminated Crutch Accessories, item 74152-060, Allegiance Crutch Tips, 3/4'' x 1-7/8''; 24 tips per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China

    FDA Recall
    Terminated ·Duro-Med Industries, Inc.·Product code INP·August 4, 2004

    Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    Allegiance Laminated Crutch Accessories, item 74152-110, Allegiance Crutch Hand Grip, CLosed Hand Style; 2 grips per package, 12 packages per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China

    FDA Recall
    Terminated ·Duro-Med Industries, Inc.·Product code INP·August 4, 2004

    Allegiance Laminated Crutch Accessories, item 74152-010, Allegiance Crutch Underarm Pad; 2 pads per package, 12 packages per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China

    FDA Recall
    Terminated ·Duro-Med Industries, Inc.·Product code INP·August 4, 2004

    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case

    FDA Recall
    Terminated ·Medical Depot Inc.·Product code INP·February 17, 2016

    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: ¿ as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) ¿ as an aid in the assessment of severity of congestive heart failure ¿ for the risk stratification of patients with acute coronary syndromes ¿ for the risk stratification of patients with heart failure The Alere Triage BNP Calibrators are intended to calibrate the Alere Triage BNP test for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·July 2, 2014

    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code NBC·October 6, 2014

    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·July 31, 2019

    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

    FDA Enforcement
    Class III ·Terminated·Abbott Laboratories·July 31, 2019

    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test)

    FDA Enforcement
    Class III ·Terminated·Siemens Healthcare Diagnostics, Inc·November 26, 2014

    ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JIT·May 24, 2019

    i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code NBC·February 1, 2012