Aniara Diagnostica LLC - BIOPHEN Protein C 5 - Class 2 Recall
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2023 Category: Medical Devices Source Type: alerts
Instrumentation Laboratory Co. - HemosIL ReadiPlasTin - Class 2 Recall
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 6, 2018 Category: Medical Devices Source Type: alerts
Instrumentation Laboratory Co. - HemosIL ReadiPlasTin - Class 2 Recall
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 Product Usage: HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2018 Category: Medical Devices Source Type: alerts
