FDA Device recall Z-2360-2016
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modifie…
- FDA Device
- Class I
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class I recall of Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modifie… by Alere San Diego, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2360-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-07-11 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.
Reason
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.
Identifiers
| code_info | All Lots All Serial Numbers |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.