Z-0132-06

HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed...

Name: Z-0132-06 HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed...
Creator: HemoSense Inc
Published: 2005-09-07
License: https://open.fda.gov/license/

Hemosense, Inc. / initiated 2005-09-07 / Terminated / root cause: software

FDA source

HemoSense Inc began a recall of HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose... on 2005-09-07. The reason FDA records is "A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0132-06
Status: Terminated
Initiated: 2005-09-07
Posted: 2005-11-15
Terminated: 2006-03-30
Recalling firm: Hemosense, Inc.
Product: HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134
Product code: GJS Test, Time, Prothrombin
Reason for recall: A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.
Root cause tag: software
FDA root cause: Other
Action: On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall.
Quantity in commerce: 123 units
Distribution: Product was released for distribution to 20 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the users who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Product codes and lots: Serial Numbers: 044609678, 051613670, 051613713, 052613997, 052614025, 044810630, 051613674, 051613714, 052613998, 052614026, 044810759, 051613675, 051613721, 052613999, 052614027, 045110807, 051613676, 051613722, 052614000, 052614028, 045110825, 051613679, 051613723, 052614002, 052614029, 051613114, 051613681, 051613730, 052614003, 052614030, 051613119, 051613682, 051613733, 052614004, 052614031, 051613121, 051613683, 051613742, 052614006, 052614032, 051613125, 051613685, 051613745, 052614007, 052614033, 051613127, 051613686, 051613746, 052614008, 052614035, 051613154, 051613687, 051613747, 052614010, 052614040, 051613156, 051613689, 051613748, 052614011, 052614042, 051613164, 051613691, 052613972, 052614012, 052614045, 051613174, 051613693, 052613975, 052614013, 052614049, 051613241, 051613695, 052613978, 052614014, 052614050, 051613247, 051613696, 052613979, 052614015, 052614051, 051613256, 051613697, 052613981, 052614016, 052614060, 051613261, 051613701, 052613984, 052614017, 052614063, 051613655, 051613702, 052613986, 052614018, 052614065, 051613656, 051613704, 052613991, 052614019, 052614072, 051613660, 051613705, 052613992, 052614020, 052614078, 051613661, 051613707, 052613993, 052614021, 052614079 051613662, 051613710, 052613994, 052614022, 052614085, 051613663, 051613711, 052613995, 052614023, 051613665, 051613712, 052613996, 052614024

Product code GJS

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)