Device product
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.
Z-0077-2019
Product summary
- Event
- Event 80932
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9751 kits
- Official record key
device-enforcement:Z-0077-2019
Official wording
Reason: There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Code information: Lot Number - N0278177 Exp. Date February 28, 2019
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.