Z-0077-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- August 1, 2018
- Termination Date
- April 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9751 kits
Product Description
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.
Reason for Recall
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Distribution Pattern
US Nationwide
Code Information
Lot Number - N0278177 Exp. Date February 28, 2019