i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24
FDA device recall Z-2361-2015 · posted 2015-08-10 · Terminated
Recall details
- Recalling firm
- Abbott Point Of Care Inc.
- Reason for recall
- Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.
- Action taken
- Abbott Point of Care sent a recall letter dated June 15, 2015 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the enclosed Business Reply Card (BRC). A Proof of Destruction From (FG-4533 in included with letter and is required to be returned to APOC as part of the credit process. Customers with questions were instructed to contact APOC Technical Support at 800-366-8020, Option 1 or their APOC representative.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 423,168 cartridges
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Mor
- Date initiated
- 2015-06-15
- Date posted
- 2015-08-10
- Date terminated
- 2016-02-19
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| I-STAT PROTHROMBIN TIME TEST (K020355) | I-Stat Corporation | 2002-05-14 |