Z-2354-2016 Class I Terminated
FDA device recall Z-2354-2016 was initiated by Alere San Diego, Inc. on Jul 11, 2016 and is designated Class I. Reason for recall: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a… The recall status is terminated (terminated Jul 20, 2017).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2016
- Initiation Date
- Jul 11, 2016
- Termination Date
- Jul 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2354-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026