Recall Z-0615-2019 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Abbott Point Of Care Inc.
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
| Date | Sep 13, 2018 |
| Status | Terminated |
| 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 |
| Root cause | Manufacturing material removal |
| Action | 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. |
| Quantity | 17550 cartridges |
| Distribution | WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER I-Stat Corp., May 10, 1994 |