FDA Device recall Z-2355-2016
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a…
- FDA Device
- Class I
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class I recall of INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a… 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-2355-2016 |
| 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
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring 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 cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the Prothrombin time test on the blood sample. The other two channels contain the reagents. to perfom the Prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control test are required for the INRatio System. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result.
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 |
|---|
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-2355-2016%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.