GEM Premier 5000 Device Recall - PCSND Errors
Summary
The FDA has issued a Class II recall for the GEM Premier 5000 device due to an increased incidence of Process Control Solution Not Detected (PCSND) errors. This recall affects worldwide distribution, including the United States.
What changed
The FDA has initiated a Class II device recall for the GEM Premier 5000, part number 00055430008, due to confirmed customer complaints of frequent Process Control Solution Not Detected (PCSND) errors during the warm-up phase. These errors can lead to GEM PAK ejection, requiring re-insertion and potentially impacting diagnostic accuracy and workflow.
Healthcare providers using the GEM Premier 5000 should be aware of this recall and monitor for PCSND errors. While the document indicates worldwide distribution, specific actions for affected entities are not detailed in this recall notice. Compliance officers should review internal device logs for error occurrences and consult Instrumentation Laboratory's advisories for any specific remediation steps or reporting requirements related to this recall.
What to do next
- Review internal logs for PCSND errors on GEM Premier 5000 devices.
- Consult Instrumentation Laboratory advisories for remediation steps.
Source document (simplified)
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,...
Source: openFDA Enforcement API
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