125 results
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Sources: EU EUDAMED, US FDA
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VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·April 30, 2014
VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·August 20, 2014
VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIX·July 15, 2014
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JFY·January 29, 2014
VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIX·October 13, 2011
Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ionexchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LCP·December 1, 2009
VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1c in EDTA human whole blood.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LCP·January 22, 2009
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LCP·October 17, 2008
VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LCP·January 22, 2009
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LCP·December 9, 2008
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine concentration. The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Clarity 10SG Urinalysis Reagent Strips (Urine) can be read visually , on the Clarity Urocheck 120 Urine Analyzers , and on the Clarity Urocheck 120C Urine Analyzers.
FDA Recall
Terminated
·Clarity Diagnostics Llc·Product code CDM·June 22, 2018
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
10430054 Acuson with Physio Module, manufactured by Siemens Medical Solutions, Mountain View, CA.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code ITX·October 2, 2009
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Recall
Terminated
·EBI Patient Care, Inc.·Product code LOE·April 20, 2017
10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYO·October 2, 2009
10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·October 2, 2009
Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 1, 2010
TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.
FDA Enforcement
Class II
·Terminated·Tec Com Gmbh·November 20, 2019
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
FDA Enforcement
Class II
·Terminated·Sorin CRM SAS·August 22, 2018
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
FDA Enforcement
Class II
·Terminated·Sorin CRM SAS·August 22, 2018