Abbott i-STAT CG8+ Cartridges intended for use in the in vitro… — Class II medical device recall Z-0615-2019
Terminated recall by Abbott Point Of Care Inc., reported 2018-12-26, distributed in WI. Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low
| Recall number | Z-0615-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Point Of Care Inc., Princeton, NJ, United States |
| Recall initiated | 2018-09-13 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2019-04-04 |
| Distributed | WI |
| Quantity | 17,550 cartridges |
| UPC / GTIN / UDI-DI | 10054749000163 |
| Lot numbers | 0221, 0222, 0223, 0224, 0231, 0232, 0233, L18059 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0615-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.