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Medium risk Medical DevicesClass II

GEM Premier 5000 PAK Cartridge Recall

GEM Premier 5000 PAK, Part No. 00055360004.

Updated January 20, 2026

GEM Premier 5000 PAK cartridges may repeatedly eject during warm-up due to detection errors, requiring cartridge replacement and potentially delaying test results. This can disrupt lab operations and slow patient care.

Is the Instrumentation Laboratory recalled? Yes. This product was recalled by FDA on January 20, 2026. Details below.

What is recalled

GEM Premier 5000 PAK (cartridges), Part No. 00055360004, manufactured by Instrumentation Laboratory.

Am I affected

You're affected if you use GEM Premier 5000 PAK cartridges (Part No. 00055360004) in your laboratory or medical facility and experience repeated cartridge ejections or "Process Control Solution Not Detected" errors during the warm-up cycle.

What to do right now

If you experience repeated cartridge ejections during warm-up, ensure you have backup cartridges on hand and advance planning in place to minimize testing delays. Contact Instrumentation Laboratory for support or guidance specific to your situation.

The hazard

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.

Brands affected

Instrumentation Laboratory
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1524-2026
Classification
Class II
Recalled
January 20, 2026
Read the official notice

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