Class 2 Device Recall GEM Premier 7000 with iQM3

• Date Initiated by Firm: May 08, 2026
• Date Posted: July 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2822-2026
• Recall Event ID: 99115
• 510(K)Number: K223608
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the GEM Premier 7000.
• Code Information: Lot Code: GEM Premier 7000: Part number: 00000015279 UDI: 0195226000924 Units distributed in US: 4 affected BCR wands on the GEM Premier 7000 in the US. GEM Premier 7000 Serial Nos. 26012062, 26012065, 26012069 and 26012070. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024015859 UDI: 08426950869634 Units distributed in US: 4
• FEI Number: 1217183
• Recalling Firm/ Manufacturer: Instrumentation Laboratory; 180 Hartwell Rd; Bedford MA 01730-2443
• For Additional Information Contact: 781-861-4467
• Manufacturer Reason for Recall: BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
• FDA Determined Cause: Software Design Change
• Action: Werfen dba Instrumentation laboratory notified consignees on about 05/08/2026 via letter and/or email. Consignees were instructed to discontinue use of the affected BCR wands immediately, manually enter patient IDs when performing testing on the GEM Premier 5000 and/or 7000 until the BCR wands have been replaced, contact Werfen Service at 1-800-955-9525 to arrange for prompt replacement of the affected BCR wands, post this notification on or near affected GEM Premier 5000 and/or 7000 instruments, and inform all laboratory staff of this notification. Consignees were also instructed to forward the notification to all affected locations within each facility, retain a copy of the notification for records, and complete and return the Mandatory Response Tracking Form within 10 days of receipt. In addition to the tracked customer notification, a Service Information (SI) 2026-09 was issued on May 11, 2026, for service personnel to track the destruction of the affected BCR wands. The Service Information includes a destruction form for service personnel to document the destruction of the affected BCR wands and to return the form to Regulatory for tracking purposes.
• Quantity in Commerce: 4 US
• Distribution: US 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 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