Class 2 Device Recall Instrumentation Laboratory (IL)

• Date Initiated by Firm: March 07, 2003
• Date Posted: May 20, 2003
• Recall Status: Terminated on May 23, 2012
• Recall Number: Z-0846-03
• Recall Event ID: 25810
• 510(K)Number: K992834
• Product Classification: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
• Product: GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. ; Part No. 24345004 (450 Sample Size); For In-Vitro Diagnostic Use
• Code Information: Lot Number: 306360 Expires: 8/31/2003
• Recalling Firm/ Manufacturer: Instrumentation Laboratory Co.; 113 Hartwell Avenue; Lexington MA 02173
• For Additional Information Contact: Carol Marble; 781-861-4467
• Manufacturer Reason for Recall: Incorrect bar code applied to cartridges could result in inaccurate pO2 value
• FDA Determined Cause: Other
• Action: IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
• Quantity in Commerce: 2
• Distribution: CA, FL, NY, PA, TN,
• 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 = INSTRUMENTATION LABORATORY CO.