5 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
FDA Recall
Open, Classified
·Helena Laboratories, Corp.·Product code GHR·May 23, 2018
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)
FDA Recall
Open, Classified
·Helena Laboratories, Corp.·Product code GHR·May 23, 2018
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 30, 2024
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CGR·September 19, 2025
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CGR·August 4, 2025