FDA Device recall Z-2361-2016
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version…
- FDA Device
- Class I
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class I recall of Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version… 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-2361-2016 |
| 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 INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.
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-2361-2016%22
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