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Class 2 Device Recall HemoSense |
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Date Initiated by Firm |
September 07, 2005 |
Date Posted |
November 15, 2005 |
Recall Status1 |
Terminated 3 on March 30, 2006 |
Recall Number |
Z-0132-06 |
Recall Event ID |
33515 |
510(K)Number |
K020679 K021923
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Product Classification |
Test, Time, Prothrombin - Product Code GJS
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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
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Code Information |
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 |
Recalling Firm/ Manufacturer |
HemoSense Inc 651 River Oaks Pkwy San Jose CA 95134-1907
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Manufacturer 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.
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FDA Determined Cause 2 |
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.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = GJS and Original Applicant = HEMOSENSE, INC.
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