FDA-Device2018-10-17Class II
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.
Instrumentation Laboratory Co.
Hazard
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Sold states
US Nationwide
Affected count
9751 kits
Manufactured in
180 Hartwell Rd, Bedford, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2019Don't want to check this manually?
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