Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT G3 Cartridge

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall iSTAT G3 Cartridge see related information
Date Initiated by Firm January 01, 2014
Date Posted March 27, 2014
Recall Status1 Terminated 3 on October 20, 2014
Recall Number Z-1306-2014
Recall Event ID 67513
510(K)Number K940918  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product i-STAT G3+ Cartridge

pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Code Information List number 03P78-25 :Lot number N13183
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact
800-323-9100
Manufacturer Reason
for Recall		 Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.
FDA Determined
Cause 2		 Process control
Action APOC sent an Urgent Recall Notice dated January 2014 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and provide a copy of this letter to any institution that was forwarded the affected product. All unused cartridges will be credited and are to be returned as instructed on the enclosed Business Reply Card. To ensure continuity of supply at their facility, customers were instructed to follow their standard process to place an order or call Customer Sedrvice at 1-800-323-9100, Option #2, then Option #9). Customers with questions were instructed to contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1 of their Abbott Point of Care representative. For questions regarding this recall call 800-323-9100.
Quantity in Commerce 48, 450 US, 1400 OUS (49,850 catridges)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada.
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.
-
-