Z-1256-2009

HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT...

Name: Z-1256-2009 HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT...
Creator: HemoSense Inc
Published: 2008-12-23
License: https://open.fda.gov/license/

Hemosense, Inc. / initiated 2008-12-23 / Terminated / root cause: manufacturing process

FDA source

HemoSense Inc began a recall of HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement... on 2008-12-23. The reason FDA records is "INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1256-2009
Status: Terminated
Initiated: 2008-12-23
Posted: 2009-05-22
Terminated: 2011-03-25
Recalling firm: Hemosense, Inc.
Product: HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Product code: GJS Test, Time, Prothrombin
Reason for recall: INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Letters for each product titled "Urgent: Medical Device Recall Notice" dated December 19, 2008 were issued explaining the problem and instructing users to discontinue use, complete the provided reply form and return the device by mail to Inverness Medical. Distributors of the violative device were instructed to contact their customers and provide the same recall information. Further questions should be addressed to HemoSense Technical Service at 1-877-441-7440.
Quantity in commerce: 921 units
Distribution: Worldwide Distribution in the US, Germany, Spain and Australia.
Product codes and lots: Product Numbers: 0200431 and 0200432.

Product code GJS

K072727Class IIInratio 2 Pt Monitoring SystemHemosense, Inc. / cleared 2007-10-26

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)