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
This recall has been terminated (originally issued September 13, 2018).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- September 13, 2018
- Terminated
- April 4, 2019
- Recall Number
- Z-0615-2019
- Quantity
- 17550 cartridges
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
WI
Lot / Code Info
Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233
Root Cause
Manufacturing material removal
Action Taken
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.