63 results
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19ms
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Sources: EU EUDAMED, US FDA
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Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DKB·August 11, 2009
Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DLZ·August 11, 2009
KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LT-D Size 5, 10-0004, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
Cardiac ResQ Kit, Size 4, CRQ424, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
Cardiac ResQ Kit , Size 3, CRQ423, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LT -D Size 4, 10-0003, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LT -D Laryngeal Tube, Size 2, KLTD202, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
KING LT -D Lanyngeal Tube, Size 3, KLTD203, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.
FDA Recall
Terminated
·King Systems Corp.·Product code CAE·December 15, 2009
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
FDA Recall
Terminated
·Beckman Coulter Inc·Product code KLT·June 11, 2003
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLT·March 5, 2014
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLT·May 26, 2005
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLT·June 12, 2013
Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code KLT·November 17, 2003