FDA Enforcement
Class II
Terminated
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: Z-0615-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0615-2019
- Event ID
- 81151
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Point Of Care Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- September 13, 2018
- Classification Date
- December 14, 2018
- Termination Date
- April 4, 2019
- Address
- 400 College Rd E, Princeton, NJ, 08540-6607, United States
Description
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
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
Code Info
Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233
Distribution
WI
Quantity
17550 cartridges