UPDATE 01/20/2015. Added the following corrections to the Class I Recall Notice:
- Under Reason for Recall – “Alere received a total of 18,924 complaints of all types for the INRatio Test Strip (Optimize) from 2013-2014."
- Under More Information about this Recall – Patients, the email address has been corrected.
UPDATE 01/09/2015. Alere INRatio and INRatio2 PT/INR Monitor System recall classified as Class I.
UPDATE 12/09/2014. Alere Inc. initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed.
The INRatio and INRatio2 PT/INR Monitor system should not be used on patients with any of the following conditions:
- Anemia of any type with hematocrit less than 30%
- Any conditions associated with elevated fibrinogen levels including:
- Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
- Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
- Severe infection (e.g., sepsis)
- Chronically elevated fibrinogen for any reason
- Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
- Any bleeding or unusual bruising, clinically observed or reported by the patient
Patients with any of the conditions listed above should immediately be transitioned to a laboratory INR method for monitoring their INR and warfarin therapy.
UPDATE 05/15/2014. Recall classified as Class I
AUDIENCE: Cardiology, Emergency Medicine, Laboratory, Nursing
ISSUE: Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory. Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths.
BACKGROUND: The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. Given these reports, Alere is concerned that the AlereINRatio2 PT/INR Professional Test Strips may report an inaccurately low INR result.
Alere will transition customers from the current Alere INRatio2 PT/INR Professional Test Strip to the Alere INRatio PT/INR Test Strip (PN 100139). The voluntary recall does not include the Alere INRatio PT/INR Test Strip (PN 100071), which is utilized by patient self-testers for home INR monitoring.
RECOMMENDATION: Healthcare professionals should immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178