Z-2355-2016Class I

INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007

Name: Z-2355-2016 INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007
Creator: Alere San Diego, Inc.
Published: 2016-07-11
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2016-07-11 / Terminated

FDA source

Alere San Diego, Inc. began a recall of INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of... on 2016-07-11. FDA classified it as Class I and gives the reason as "Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 PT/INR Monitoring Systems (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2355-2016
Classification: Class I
Status: Terminated
Initiated: 2016-07-11
Posted: 2016-08-19
Terminated: 2017-07-20
Recalling firm: Alere San Diego, Inc.
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.
Product code: GJS Test, Time, Prothrombin
Reason for recall: Alere San Diego is initiating a voluntary recall for the Alere INRatio/INRatio2 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/INRatio2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
FDA root cause: Other
Action: Alere issued a press release on July 11, 2016. An Urgent Medical Device Letter dated July 26, 2016 was sent to affected customers on July 29, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to consult with their healthcare provider as soon as possible to transition to an alternate method of PT/INR testing and to contact the firm regarding return or disposal of unused product and obtaining device replacement from a different manufacturer. For questions contact the Alere INRatid1 Recall Hotline at 1-866-723-2535.
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, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.
Product codes and lots: All Lots All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2355-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2354-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2355-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2356-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2357-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2358-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2359-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2360-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2361-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19
Z-2362-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-19

Product code GJS

K020679Class IIInratioHemosense, Inc. / cleared 2002-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)