Urgent Field Safety Notice For Gem Premier 5000 Pak Bg/ise/gl/coox By Instrumentation Laboratory Company

Summary Instrumentation Laboratory Company has issued an urgent safety notice for GEM Premier 5000 PAK BG/ISE/GL/COOX blood gas analyzers distributed in Germany and the EU. This is a Class I recall, indicating a serious issue with the device. The specific reason for the recall is not detailed in the information provided.

Recalling firm
Instrumentation Laboratory Company
Product
GEM Premier 5000 PAK BG/ISE/GL/COOX
Reason
Urgent Field Safety Notice for GEM Premier 5000 PAK BG/ISE/GL/COOX by Instrumentation Laboratory Company
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-07-29
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/0253370a-6134-4389-85ae-579c9e76c768