Class 2 Device Recall GEM Premier 5000 PAK

• Date Initiated by Firm: January 20, 2026
• Date Posted: March 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1524-2026
• Recall Event ID: 98349
• 510(K)Number: K203790
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: GEM Premier 5000 PAK, Part No. 00055360004.
• Code Information: Part number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X.
• FEI Number: 1217183
• Recalling Firm/ Manufacturer: Instrumentation Laboratory; 180 Hartwell Rd; Bedford MA 01730-2443
• For Additional Information Contact: Keith Kelly; 732-379-2123
• Manufacturer Reason for Recall: Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT MEDICAL DEVICE CORRECTION notice was sent to consignees on 1/20/26 was sent to consignees. The notice instructs consignees to continue to use affected devices with the provided warmup instructions. Consignees are to inform all laboratory staff of this notification and forward the notification if product was further distributed. A copy of the notification is to be maintained in consignee records. Consignees may contact Werfen Technical Support at 1-800-678-0710 for a replacement if a GEM PAK experiences a Process Control Solution Not Detected error.
• Quantity in Commerce: 51 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.
• 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