Recall Z-0615-2019— Abbott Point Of Care Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2018-09-13, terminated 2019-04-04. It names one FDA 510(k) clearance: K940918. 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.
- Recalling firm
- Abbott Point Of Care Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-13
- Terminated
- 2019-04-04
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.