Class 2 Device Recall iSTAT CHEM 8 Cartridge

• Date Initiated by Firm: February 15, 2011
• Date Posted: April 18, 2011
• Recall Status: Terminated on July 10, 2012
• Recall Number: Z-2022-2011
• Recall Event ID: 58041
• 510(K)Number: K053110
• Product Classification: Electrode, ion specific, sodium - Product Code JGS
• Product: i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
• Code Information: 510 K053110; Lot # C10247 boxes 0532 through 0593
• FEI Number: 2245578
• Recalling Firm/ Manufacturer: Abbott Point Of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: Mr. Peter J. Scott; 609-454-9000
• Manufacturer Reason for Recall: i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
• FDA Determined Cause: Other
• Action: The firm, Abbott Point of Care (APOC), sent an "Urgent Recall Notice" letter dated February 2011 with business reply cards attached via Fed Ex overnight to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of cartridges from the box numbers of identified lots; discontinue use as a precaution, if their cartridges are no longer traceable to a specific box; return all unused cartridges as instructed on the enclosed Business Reply Card; if they've provided another institution with the cartridges, provide the institution with a copy of this letter, and complete and return the business reply card to APOC. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-336-8020, Option 1 or your Abbott Point of Care representative.
• Quantity in Commerce: 6575 cartirdges
• Distribution: Nationwide distribution.
• 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 = JGS