Instrumentation Laboratory Co. recalls Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagno…

Recall date

August 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0077-2019

FDA classification

Class II

Brand / firm

Instrumentation Laboratory Co.

Sold / distributed

US Nationwide

Why it was recalled

There is a potential for increased imprecision, out of range quality controls and prolonged sample results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.