Z-0615-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- September 13, 2018
- Termination Date
- April 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17550 cartridges
Product 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 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 Pattern
WI
Code Information
Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233