FDA recall Z-0077-2019

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.

Reason for recall

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

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2018-08-01

Report date

2018-10-17

Termination date

2019-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2019