816 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
FDA Recall
Terminated
·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·July 9, 2019
Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
FDA Recall
Terminated
·Nichols Institute Diagnostics·Product code DHA·August 31, 2005
Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
FDA Recall
Terminated
·Nichols Institute Diagnostics·Product code DHA·August 31, 2005
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
FDA Recall
Terminated
·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code DHA·November 21, 2018
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
FDA Recall
Terminated
·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code DHB·November 20, 2017
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
FDA Recall
Open, Classified
·Abbott Laboratories·Product code DHA·November 24, 2022
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025
Pollen Allergy Test
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHB·May 6, 2015
IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DHB·January 2, 2018
Allergy test Small
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025
Food Intolerance Test Small
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025
Food Sensitivity Test Medium
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code DHA·February 22, 2022
Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
FDA Recall
Terminated
·BioCheck Inc·Product code DHA·December 22, 2010
Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code DHA·November 11, 2015