21 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hyperbox System
FDA UDI
AOTI LIMITED·05391518749990·The Hyper-Box Homecare System is intended to be...
Hyperbox System
FDA UDI
AOTI LIMITED·05391518740027·The Hyper-Box Topical Wound Oxygen System is in...
C.F.A.S. PROTEINS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JIX·August 16, 2017
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·April 12, 2017
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
FDA Enforcement
Class II
·Terminated·K2M, Inc·December 9, 2020
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
FDA Recall
Terminated
·Product code NKG·November 3, 2020
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
FDA Recall
Terminated
·Diasorin Inc.·Product code MID·November 1, 2004
DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285
FDA Recall
Terminated
·Diasorin Inc.·Product code MID·January 23, 2004
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020
HemosIL LMW Heparin Controls; Part Number: 0020300200;
FDA Enforcement
Class II
·Ongoing·Instrumentation Laboratory·August 20, 2025
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).
FDA Recall
Terminated
·Diasorin Inc.·Product code JZO·April 12, 2004
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
FDA Recall
Terminated
·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 2020
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.
FDA Recall
Terminated
·Diasorin Inc.·Product code MSV·October 26, 2004
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.
FDA Enforcement
Class II
·Terminated·BioMerieux SA·June 20, 2018
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·December 18, 2024
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·March 16, 2017
HemosIL LMW Heparin Controls; Part Number: 0020300200;
FDA Recall
Open, Classified
·Instrumentation Laboratory·Product code KFF·February 3, 2025
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
FDA Recall
Terminated
·Diamedix Corporation·Product code LIP·September 11, 2003
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code KXT·July 20, 2007
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
FDA Recall
Open, Classified
·Draeger Medical, Inc.·Product code CBK·January 23, 2023