Class 1 Device Recall Instrumentation Laboratory

• Date Initiated by Firm: May 31, 2011
• Date Posted: July 21, 2011
• Recall Status: Terminated on November 27, 2012
• Recall Number: Z-2804-2011
• Recall Event ID: 58996
• 510(K)Number: K093623
• Product Classification: Electrode, ion specific, potassium - Product Code CEM
• Product: GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters
• Code Information: All in date cartridges
• Recalling Firm/ Manufacturer: Instrumentation Laboratory Co.; 180 Hartwell Road; Bedford MA 01730-2443
• For Additional Information Contact: SAME; 781-861-4467
• Manufacturer Reason for Recall: K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, Instrumentation Labs, issued a Revised "Urgent Field Safety Notification" letter dated July 14, 2011, to GEM Premier 4000 customers. The letter describes the product, problem, updated issue description and actions to be taken. The customers were instructed to follow the instructions to Disable K+ Parameter ,provided in the letter, to eliminate the potential of erroneous K+ result reporting and to complete and return the MANDATORY RESPONSE TRACKING FORM immediately via fax at 781-861-4207 or email to ra-usa@ilwww.com. The letter also noted an Important Change to Customer Actions from June Urgent Field Safety Notification. Prior strategy : Instrumentation Laboratories (IL) notified U.S and Canadian customers via the Urgent Field Safety Notification mailed USPS between June 2 - 3,2011. International Affiliates / Dealers notified through e-mail on June 1, 2010. A response (tracking) form was included. A Worldwide Regulatory Notice was e-mailed on May 31.2011.to IL country affiliates and distributors, notifying them of the issue, providing a risk summary and the support documentation for the notification. The customer notification will be handled per their local regulatory requirements. If you have questions regarding this notification, please contact IL at 800-678-0710, press 2 at prompt.
• Quantity in Commerce: 24787
• Distribution: Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PANAMA, POLAND, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.
• 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 = CEM