Instrumentation Laboratory

Device Recalls (Class II)

← All Device Recalls (Class II)
Class II Z-1538-2026 · 20260318 · Ongoing

Product

GEM Premier 5000; Part No. 00055430008.

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,...