Instrumentation Laboratory: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Recall Summary Instrumentation Laboratory is recalling GEM Premier 5000 blood gas analyzers with BCR wands that received a specific software update (Service Information No. 2026-07, released on or after April 8, 2026). Due to a technical error, these devices may assign blood test results to the wrong patient ID, causing one patient's results to be recorded under another patient's name. This has been distributed nationwide across all U.S. states and territories.
- Recalling firm
- Instrumentation Laboratory
- Product
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Intelligent Quality Management 2 (iQM2) is used as the quality control and assessment system for the GEM Premier 5000 system.
- 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/82c148b2-1838-4562-b2f9-dcc3154164b9