Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GEM Premier 5000 PAK Recalled by Instrumentation Laboratory Due to Confirmed customer complaints indicating that GEM PAKs (cartridges)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentation Laboratory directly.
Affected Products
GEM Premier 5000 PAK, Part No. 00055360004.
Quantity: 51 units
Why Was This Recalled?
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 a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Instrumentation Laboratory
Instrumentation Laboratory has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report