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Sources: EU EUDAMED, US FDA
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FDA Recall
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ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA and Abbott, 65205 Wiesbaden, Germany; list 3L53-25 The ARCHITECT C-Peptide assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System. The ARCHITECT C-Peptide assay is used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
FDA Recall
Terminated
·Abbott Laboratories·Product code JKD·July 11, 2011
biokitHSV-2 Rapid Test, REF: 300028001
FDA Recall
Open, Classified
·Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain·Product code LGC·September 28, 2022