Class 2 Device Recall iSTAT CG8 Cartridge

• Date Initiated by Firm: August 03, 2010
• Date Posted: January 20, 2011
• Recall Status: Terminated on December 05, 2011
• Recall Number: Z-0929-2011
• Recall Event ID: 56403
• 510(K)Number: K940918
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: i-STAT CG8+ Cartridge;; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD; Abbott Point of Care; The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
• Code Information: List number 03M86-01, 03M86-02, lot number T10036A
• Recalling Firm/ Manufacturer: Abbott Point of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: Peter J. Scott; 609-454-9270
• Manufacturer Reason for Recall: Two cartridge lots were identified that may generate falsely elevated PCO2 results.
• FDA Determined Cause: Other
• Action: Abbott Point of Care Inc. sent an Urgent Recall Notice letter dated July 2010 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 cartridges from the identified lots and follow the instructions on the enclosed reply card to receive replacement cartridges. If cartridges were distributed from the lot numbers to another institution, a copy of the recall letter should be provided to them. For any questions regarding this recall contact Abbott-Point of Care Technical Support at 800-366-8020, Option 1.
• Quantity in Commerce: 55350 total cartridges
• Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of Oman and Turkey.
• 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.