FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
- Recall number
- Z-2157-2012
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
- Status
- Terminated
- Initiated
- 2012-03-01
- Posted
- 2012-08-08
- Terminated
- 2013-02-08
- Reason
- The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
- Root cause
- Process control
- Action
- Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.
- Quantity
- 2,950,296 cartridges US; 156,408 cartridges OUS
- Distribution
- Worldwide Distribution -- (USA) nationwide
- Lot, serial or model codes
- List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12
- 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