7 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·May 4, 2016
ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·May 4, 2016
Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. North Coast Medical Inc. 8100 Camino Arroyo Gilroy, CA 95020 Comfort and safety in shower
FDA Recall
Terminated
·North Coast Medical Inc 8100 Camino Arroyo·Product code IKX·March 20, 2012
Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R
FDA Recall
Terminated
·Nutech Manufacturing Corp·Product code IKX·July 9, 2009
IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060 The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids. The Beckman Coulter IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top analyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs. The system methodologies are rate turbidimetry and rate nephelometry.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code LDT·August 24, 2010
ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Recall
Terminated
·Horiba Instruments Inc·Product code JJE·February 19, 2016
Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Recall
Terminated
·Horiba Instruments Inc·Product code JJE·February 19, 2016