Instrumentation Laboratory
Device Recalls (Class II)
Class II
Z-1533-2026
·
20260318
·
Ongoing
Product
GEM Premier 5000; Part No. 00055415005.
Reason for Recall
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of ...
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada,...
Source: openFDA Enforcement API