Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Recall Summary Instrumentation Laboratory is recalling GEM Premier 7000 blood gas analyzers with iQM3 quality control systems that received a specific software update on or after April 8, 2026. A software error can cause patient test results to be assigned to the wrong patient ID, meaning blood work from one patient could be labeled with another patient's information. This recall affects devices distributed nationwide across all U.S. states and the District of Columbia.
- Recalling firm
- Instrumentation Laboratory
- 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.
- 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/fb2ebd5e-a434-4797-b2e7-e6dde461b4a7