Class 2 Device Recall GEM Premier 3000 NoniQM PAKs

• Date Initiated by Firm: September 29, 2023
• Date Posted: November 21, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0358-2024
• Recall Event ID: 93313
• 510(K)Number: K161818 K992834
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
• Code Information: Part No. 00024307507: UDI-DI: 08426950087946, Lot Numbers: 323031H, 323531D, 324231M, 325031D, 324931F, 323831E, 323031I, 324231I, 324831E, 325631C; Part No. 00024315007: UDI-DI: 08426950082484, Lot Numbers: 323441B, 323641G, 323041H, 323541D, 324141J, 324841E, 325041D, 325641C; Part No. 00024330007: UDI-DI: 08426950082514, Lot Numbers: 323051H, 323551D, 323651G, 324151J; Part No. 00024345007: UDI-DI: 08426950082545, Lot Numbers: 323761H; Part No. 00024360007: UDI-DI: 08426950082569, Lot Numbers: 323771H, 323471B, 324871E
• FEI Number: 1217183
• Recalling Firm/ Manufacturer: Instrumentation Laboratory; 180 Hartwell Rd; Bedford MA 01730-2443
• For Additional Information Contact: Technical Support Center; 800-678-0710
• Manufacturer Reason for Recall: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 9/29/23 was sent to customers. Mandatory Customer Actions Please take the following immediate actions: " Check your inventory for the GEM Premier 3000 Non-iQM PAK (cartridge) lot numbers listed in Appendix A. " Discontinue use and destroy any GEM Premier 3000 Non-iQM PAK (cartridge) lot numbers listed in Appendix A. " Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to Werfen Regulatory at the fax number or e-mail address listed below. " Contact Werfen Customer Service at 1-800-955-9525 to order replacement PAKs (cartridges). " Share this information with your laboratory staff and follow your internal procedures. " Forward this notification to all affected locations within your facility. " Retain a copy of this notification for your records. Mandatory Response Tracking Record " Return the completed and signed Mandatory Response Tracking Form to: " Fax No.: 1-781-861-4207 Or " E-mail: ra-usa.na@werfen.com Contact Information for Questions " For technical questions, contact the Technical Support Center at 1-800-678-0710. " For replacement cartridges, contact Customer Service at 1-800-955-9525.
• Quantity in Commerce: 2448 units
• Distribution: US States: MA, MN, NY. India.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CHL