32 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.
FDA Recall
Terminated
·Bio-Rad Laboratories·Product code LKJ·November 13, 2007
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Recall
Terminated
·Euro Diagnostica AB·Product code LKJ·May 22, 2017
is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.
FDA Recall
Terminated
·Euro Diagnostica AB·Product code LKJ·October 21, 2016
Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·February 24, 2010
Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·February 26, 2010
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
FDA Recall
Terminated
·Euro Diagnostica AB·Product code LKJ·October 15, 2015
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
FDA Recall
Terminated
·Bio-Rad Laboratories, Inc.·Product code LKJ·November 1, 2019
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
FDA Recall
Terminated
·Euro Diagnostica AB·Product code LKJ·February 14, 2017
DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010
Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010
Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·June 24, 2010
Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010
Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN manufactured by Bio-Rad, Hercules, CA.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code LKJ·March 1, 2010
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
FDA Enforcement
Class II
·Terminated·Angiotech (Manan Medical Products, Inc.)·February 13, 2019
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009