42 results · 16ms · Sources: EU EUDAMED, US FDA

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VITEK 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton.

FDA Recall
Terminated ·Biomerieux Inc·Product code NGZ·April 20, 2017

ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333

FDA Recall
Open, Classified ·Biomerieux Inc·Product code NGZ·November 9, 2022

VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226

FDA Recall
Open, Classified ·Biomerieux Inc·Product code NGZ·November 9, 2022

Yeastone Broth, 11ML, 10/BOX YY3462

FDA Recall
Open, Classified ·Remel, Inc·Product code NGZ·March 24, 2026

Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests

FDA Recall
Terminated ·Roche Molecular Systems, Inc.·Product code JJF·May 21, 2007

Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

FDA Recall
Terminated ·Abaxis Inc·Product code JJG·December 11, 2019

ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

FDA Recall
Terminated ·Sendx Medical Inc·Product code CHL·February 20, 2009

ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code CGZ·June 10, 2004

Extension Line Slide Clamps; Product codes: SA-09847

FDA Recall
Terminated ·Arrow International Inc·Product code KGZ·April 11, 2018

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code KGZ·October 29, 2025

Arrow Percutaneous Sheath Introducers

FDA Recall
Terminated ·Arrow International Inc·Product code KGZ·February 11, 2009

Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

FDA Recall
Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

FDA Recall
Terminated ·Cook Inc.·Product code KGZ·February 1, 2017

Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

FDA Recall
Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT

FDA Recall
Terminated ·Cook Inc.·Product code KGZ·May 2, 2019

Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

FDA Recall
Terminated ·Cook Inc.·Product code KGZ·April 15, 2016

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code CGZ·August 28, 2018

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062.

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code KGZ·October 29, 2025

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019