36 results
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Sources: EU EUDAMED, US FDA
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UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·October 6, 2014
Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·October 6, 2014
Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code MFC·June 22, 2009
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270 and 3 minutes at 11357275re-vacuum steam sterilizers.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·June 10, 2013
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121C, 132C, 134C and 135C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135 pre-vacuum steam sterilizers.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code FRC·June 10, 2013
Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·June 10, 2013
Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
FDA Recall
Terminated
·Nidek Inc·Product code HKI·June 16, 2014
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
FDA Recall
Terminated
·Merge Healthcare, Inc.·Product code HKI·December 9, 2016
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
FDA Recall
Terminated
·Nidek Inc·Product code HKI·August 1, 2013
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
FDA Recall
Terminated
·Merge Healthcare, Inc.·Product code HKI·December 9, 2016
AXIOM Artis dFC, Model Number 7412807
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis dFC, Model Number 7727717
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·December 4, 2023