FDA Device recall Z-0615-2019
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood by Abbott Point, citing inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0615-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-13 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Abbott Point |
| Distribution | WI |
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
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
Identifiers
| code_info | Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2019%22
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