Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Recall Summary Instrumentation Laboratory is recalling GEM Premier 5000 blood analysis systems nationwide because a recent software update can cause patient blood test results to be assigned to the wrong patient. The problem occurs when data from a previous patient scan is transmitted instead of the current patient's scan due to a technical error. This could lead to incorrect test results being attributed to the wrong person, potentially causing inappropriate medical treatment.
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b7d796b4-da72-4c2d-b670-5df1ec4d0660