13 results
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8ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Recall
Terminated
·Product code GKR·February 8, 2018
Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403
FDA Recall
Terminated
·Skf USA Inc·July 24, 2007
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
FDA Recall
Terminated
·Pinook-Usa·Product code NGX·May 23, 2013
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
FDA Recall
Terminated
·Pinook-Usa·Product code NGX·May 23, 2013
ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.
FDA Recall
Terminated
·Linvatec Corp.·Product code KFK·December 20, 2005
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box.
FDA Recall
Terminated
·Radiometer America Inc·Product code GKF·May 24, 2005
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood - 2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
FDA Recall
Terminated
·International Technidyne Corp.·Product code KFF·June 24, 2010
Berichrom Heparin Reagent (OWLD11). The reagent is a component in a test kit.
FDA Recall
Terminated
·Dade Behring Inc. Rte 896, Glasgow Business Community·Product code KFF·June 7, 2004
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
FDA Recall
Terminated
·Diagnostica Stago, Inc.·Product code KFF·July 18, 2014