Class 2 Device Recall GEM Premier 5000

• Date Initiated by Firm: May 08, 2026
• Date Posted: July 29, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2826-2026
• Recall Event ID: 99115
• 510(K)Number: K203790
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• Product: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples. Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system. iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during, and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls (QC). Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. The GEM Premier 5000 system makes use of potentiometric sensors to measure pCO2, pH, Na+, K+, Cl-, and Ca++. It uses amperometric sensors to measure pO2, glucose, and lactate concentrations. Blood conductivity is the method used to measure hematocrit. CO-Oximetry and total bilirubin measurements involve chemically lysing the whole blood sample and then utilizing a broad spectrum spectrophotometer to evaluate the sample at a variety of wavelengths.
• Code Information: Lot Code: GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: 3 affected BCR wands on the GEM Premier 5000 in Argentina. GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: 3
• 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: 3
• 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