FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
- Recall number
- Z-0451-2014
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
- Status
- Terminated
- Initiated
- 2013-10-28
- Posted
- 2013-12-04
- Terminated
- 2014-05-29
- Reason
- Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
- Root cause
- Nonconforming Material/Component
- Action
- Abbott Point of Care Inc. (APOC) issued an Urgent Recall Notice on October 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from PT/INR lots in this letter. All unused cartridges would be credited and are to be returned as instructed on the enclosed Business Reply Card. If customers provided cartridges from the lot number listed above to another institution they were instructed to provide a copy of this letter to them. Customers with questions were instructerd to contact Abbott Point of Care Technical at 1-800-366-8020, Option 1. For questions regarding this recall call 800-366-8020.
- Quantity
- 794,928 units US; 119,472 units OUS
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,
- Lot, serial or model codes
- K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A
- 510(k) numbers
- ["K020355"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 2245578
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28