Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Recall Summary Instrumentation Laboratory is recalling GEM Premier 5000 blood analysis systems with certain BCR wands (bar code readers) that received a software update on or after April 8, 2026. Due to a technical glitch, these wands may assign blood test results to the wrong patient ID, meaning a patient could receive test results that belong to another patient. This affects facilities nationwide that use this equipment.

Recalling firm: Instrumentation Laboratory
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...
Reason: 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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-08
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: US Nationwide distribution.

Recall details on Nibble Recalls: https://trynibble.app/recalls/7de60e97-85ce-4bc9-8e49-393411fd08a2