FDA Medical Device Recalls (openFDA)
Abbott Point Of Care Inc.: Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
- Recall number
- Z-0615-2019
- Recalling firm
- Abbott Point Of Care Inc.
- Product
- Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059
- Status
- Terminated
- Initiated
- 2018-09-13
- Posted
- not on file
- Terminated
- 2019-04-04
- Reason
- Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated
- Root cause
- Manufacturing material removal
- Action
- Abbott Point of Care issued recall letter on 9/13/18 via FedEx , advising of the problem, recommend action to return all unused cartridges to APOC . If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 844-256-9531 or your Abbott Point of Care representative.
- Quantity
- 17550 cartridges
- Distribution
- WI
- Lot, serial or model codes
- Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233
- 510(k) numbers
- ["K940918"]
- PMA numbers
- not on file
- Product code
- CHL
- 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