CLASS I Device recall · Reported 31 Aug 2016 · FDA Enforcement Report
INRatio Prothrombin Time (PT) Monitoring System recalled
Alere San Diego is recalling INRatio Prothrombin Time (PT) Monitoring System, distributed nationwide in the US. The recall was initiated on 11 Jul 2016 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2355-2016
- FDA event ID
- 74665
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Jul 2016
- FDA classified
- 19 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 11 Jul 2016 | Recall initiated by company | |
| 19 Aug 2016 | Classified by FDA | +39 days |
| 31 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Lots All Serial Numbers
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 74665This product is part of a recall event; the main page for the event is Alere INRatio PT/INR Test Strips recalled by Alere San Diego.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Alere INRatio PT/INR Test Strips recalled by Alere San Diego | Alere San Diego | Temperature Abuse | Nationwide | |
| CLASS I | Alere INRatio2 Replacement Monitor (Home) recalled by Alere San Diego | Alere San Diego | Other | Nationwide | |
| CLASS I | Alere INRatio2 PT/INR Professional Monitoring System recalled | Alere San Diego | Other | Nationwide | |
| CLASS I | Alere INRatio/ INRatio2 PT/INR Test Strips recalled by Alere San Diego | Alere San Diego | Other | Nationwide | |
| CLASS I | Alere INRatio2 PT/INR Professional Testing System recalled | Alere San Diego | Other | Nationwide | |
| CLASS I | Alere INRatio Replacement Monitor recalled by Alere San Diego | Alere San Diego | Other | Nationwide | |
| CLASS I | Alere INRatio2 PT/INR Home Monitoring System recalled by Alere San Diego | Alere San Diego | Other | Nationwide | |
| CLASS I | Alere INRatio PT/INR System Professional recalled by Alere San Diego | Alere San Diego | Other | Nationwide |
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| Device | CLASS II | Fisher Scientific Sure-Vue Serum/Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Abbott Cholestech LDX Battery Kit recalled by Alere San Diego | Alere San Diego | E. coli | Nationwide |
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