FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
- Recall number
- Z-0399-2011
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
- Status
- Terminated
- Initiated
- 2010-10-06
- Posted
- 2010-11-17
- Terminated
- 2012-08-22
- Reason
- Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
- Root cause
- Other
- Action
- Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US 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 the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.
- Quantity
- 49,025 cartridges.
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- List numbers: 07G01-01, 07G01-02,. 600-9006-25; Lot numbers: S10127B, S10136A, S10150A, S10151, S10155.
- 510(k) numbers
- ["K992571"]
- PMA numbers
- not on file
- Product code
- JBP
- 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