Home / Recalls / Alere San Diego, Inc. / Z-2356-2016

Z-2356-2016 Class I Terminated

Recalled by Alere San Diego, Inc. — San Diego, CA

FDA device recall Z-2356-2016 was initiated by Alere San Diego, Inc. on July 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 Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a t… The recall status is terminated (terminated July 20, 2017).

Recall Details

Product Type
Devices
Report Date
August 31, 2016
Initiation Date
July 11, 2016
Termination Date
July 20, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.

Reason for Recall

Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.

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

All Lots All Serial Numbers

Other recalls by Alere San Diego, Inc.

  • Z-1702-2024 Class II — Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 (March 1, 2024)
  • Z-1508-2022 Class II — The Cholestech LDX¿ System combines enzymatic methodology and solidphase techno (June 24, 2022)
  • Z-2475-2019 Class II — Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the (February 15, 2019)
  • Z-0418-2018 Class II — Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 2 (November 14, 2017)
  • Z-0588-2017 Class II — Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the prod (October 12, 2016)
  • Z-2778-2016 Class III — LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette i (August 2, 2016)
  • Z-2357-2016 Class I — Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Prod (July 11, 2016)
  • Z-2361-2016 Class I — Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usag (July 11, 2016)
  • Z-2359-2016 Class I — Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usag (July 11, 2016)
  • Z-2362-2016 Class I — Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 9900 (July 11, 2016)

FDA data resources