15 results
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68ms
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Sources: EU EUDAMED, US FDA
Axis-Shield Diagnostics Ltd
Manufacturer
2 Importers
AXIS-SHIELD DIAGNOSTICS, LTD.
FDA registration
AXIS-SHIELD DIAGNOSTICS, LTD.·14 products·🇬🇧 United Kingdom
AXIS SHIELD ACTIVE-B12 EIA
FDA Adverse Event
Malfunction
·AXIS-SHIELD DIAGNOSTICS, LTD.·Product code CDD·July 17, 2024
IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code NRP·August 11, 2006
IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA; list 5C91-21 The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
FDA Recall
Terminated
·Abbott Laboratories·Product code NRP·April 30, 2010
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
FDA Enforcement
Class II
·Terminated·Axis-Shield Diagnostics, Ltd.·July 8, 2015
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Enforcement
Class II
·Ongoing·Axis-Shield Diagnostics, Ltd.·January 1, 2020
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Enforcement
Class II
·Ongoing·Axis-Shield Diagnostics, Ltd.·January 1, 2020
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Enforcement
Class II
·Ongoing·Axis-Shield Diagnostics, Ltd.·January 1, 2020
Abbott Rapid Dx International Limited
Authorized representative
🇮🇪 Ireland·5 Manufacturers·4 Devices
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Recall
Open, Classified
·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Recall
Open, Classified
·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
FDA Recall
Open, Classified
·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019
Abbott Rapid Dx International Limited
Importer
🇮🇪 Ireland·11 Manufacturers
BC Distribution B.V.
Importer
🇳🇱 Netherlands·13 Manufacturers