HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense
FDA device recall Z-0132-06 · posted 2005-11-15 · Terminated
Recall details
- Recalling firm
- HemoSense Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 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 shipmen
- Date initiated
- 2005-09-07
- Date posted
- 2005-11-15
- Date terminated
- 2006-03-30
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INRATIO SELF-TEST (K021923) | Hemosense, Inc. | 2002-10-24 |
| INRATIO (K020679) | Hemosense, Inc. | 2002-05-06 |