Z-0077-2019 Class II Terminated
FDA device recall Z-0077-2019 was initiated by Instrumentation Laboratory Co. on Aug 1, 2018 and is designated Class II. Reason for recall: There is a potential for increased imprecision, out of range quality controls and prolonged sample results. The recall status is terminated (terminated Apr 16, 2019). Affected quantity: 9751 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2018
- Initiation Date
- Aug 1, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0077-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026