Instrumentation Laboratory Class II Recall Z-1533-2026

FDA: Device Recalls Class II

Filed January 20th, 2026

Detected March 23rd, 2026

Summary

The FDA has issued a Class II recall for Instrumentation Laboratory's GEM Premier 5000 device due to an increased incidence of 'Process Control Solution Not Detected' errors. The recall, initiated voluntarily by the firm, affects approximately 8 units distributed worldwide.

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What changed

The FDA has classified a recall of Instrumentation Laboratory's GEM Premier 5000 device (Part No. 00055415005) as Class II, indicating that use of or exposure to a problematic product may cause temporary or medically reversible adverse health consequences. The recall, initiated voluntarily by the firm on January 20, 2026, is due to customer complaints of frequent 'Process Control Solution Not Detected' errors during warm-up, leading to GEM PAK ejection and potential operational disruption. Approximately 8 units are affected, with distribution reported worldwide.

While the FDA notes that many GEM PAKs continue to perform as intended and the issue may not necessitate immediate patient reassessment, consecutive ejections can prolong turnaround times. This could delay critical results, potentially impacting patient management. Companies involved in the distribution or use of this device should review their inventory, understand the potential for operational disruption, and ensure appropriate contingency plans are in place to manage any delays in obtaining results. The recall status is currently 'Ongoing'.

What to do next

Review inventory of GEM Premier 5000 devices and associated GEM PAK cartridges.
Assess potential for operational disruption due to 'Process Control Solution Not Detected' errors.
Implement contingency plans to manage potential delays in test results.

Source document (simplified)

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