FDA Devices recall · Reported August 31, 2016
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 dis
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…
Alere San Diego, Inc. recalled Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usa… - a critical-severity action.
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usa… was recalled by Alere San Diego, Inc. in August 31, 2016. Reason: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (…. Check the official notice for the remedy. Verify recall #Z-2360-2016 with the FDA Devices before acting.
The recall
Alere San Diego, Inc. issued this critical-severity FDA Devices recall-Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (….
- Critical
- severity level
- Class I
- classification
- August 31, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2360-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2360-2016 |
| Date reported | August 31, 2016 |
| Date initiated | July 11, 2016 |
| Recalling firm | Alere San Diego, Inc. |
| Firm location | San Diego, CA |
| Affected scope | Not disclosed |
| Distribution | 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, In… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2360-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026