FDA Class II Device Recall: GEM Premier 5000 PAK
Summary
The FDA has issued a Class II device recall for Instrumentation Laboratory's GEM Premier 5000 PAK due to an increased incidence of Process Control Solution Not Detected (PCSND) errors. This recall affects worldwide distribution, including the US.
What changed
The FDA has classified a recall of Instrumentation Laboratory's GEM Premier 5000 PAK (Part No. 00055360008) as Class II. The recall is due to confirmed customer complaints indicating an increased incidence of "Process Control Solution Not Detected" (PCSND) errors during warm-up, leading to GEM PAK ejection. This issue requires the insertion of a new cartridge.
Healthcare providers and facilities using the GEM Premier 5000 system should be aware of this recall and potential operational disruptions. While the document does not specify a compliance deadline for action, affected parties should consult Instrumentation Laboratory for guidance on addressing the PCSND errors and potential remediation steps. The recall has worldwide distribution, including the United States.
What to do next
- Review GEM Premier 5000 PAK usage for PCSND errors.
- Consult Instrumentation Laboratory for remediation guidance.
- Ensure affected devices are properly managed according to manufacturer instructions.
Source document (simplified)
Instrumentation Laboratory
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1525-2026 · 20260318 · Ongoing
Product
GEM Premier 5000 PAK; Part No. 00055360008.
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
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