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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott iStat

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  Class 2 Device Recall Abbott iStat see related information
Date Initiated by Firm September 13, 2018
Create Date December 14, 2018
Recall Status1 Terminated 3 on April 04, 2019
Recall Number Z-0615-2019
Recall Event ID 81151
510(K)Number K940918  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
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
Code Information Lot Number: L18059 Box Numbers: 0221, 0222, 0223, 0224, 0231, 0232, 0233 
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact SAME
609-454-9000
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 17550 cartridges
Distribution WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = I-STAT CORP.
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