25 results · 13ms · Sources: EU EUDAMED, US FDA

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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 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

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m

FDA Recall
Open, Classified ·CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel·Product code QWU·August 18, 2025

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

FDA Recall
Open, Classified ·CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel·Product code QWU·October 16, 2024

EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202

FDA Recall
Open, Classified ·CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel·Product code QWU·August 18, 2025

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 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
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

Food Allergy Panel Test (IgE)

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

Food Sensitivity Test Large

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

Pet Allergy Test

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

Food Intolerance Test Large

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

FDA Recall
Open, Classified ·Quidel Corporation·Product code DBA·February 1, 2023

Food Intolerance Test Medium

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

Food Sensitivity Test Small

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

Allergy Test IgE

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 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
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.

FDA Recall
Open, Classified ·Hycor Biomedical LLC·Product code DHB·July 25, 2018

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 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
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 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