GEM recalls PAK cartridges for Premier 5000 that may cause repeated process errors during warm-up, requiring frequent replacements and delaying test results.
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.
GEM is recalling specific PAK cartridges for its Premier 5000 device because they sometimes cause repeated errors during warm-up, requiring frequent replacements and potentially delaying test results. This could affect patient care if tests are delayed.
The PAK cartridges may cause repeated errors during warm-up, leading to the device ejecting the cartridge and requiring a new one. This can prolong test turnaround times and potentially delay patient care if results are needed urgently.
Healthcare facilities using the GEM Premier 5000 device with the recalled PAK cartridges are most affected. Patients may experience delays in test results if the device requires frequent cartridge replacements.
Check for the part number 00055407510 on the cartridge. The lot numbers listed in the recall include 251114J through 251231E. These cartridges were sold with the GEM Premier 5000 device.
Look for the lot number on the cartridge, which should match one of the listed numbers (251114J through 251231E).
The recall is due to confirmed customer complaints that the PAK cartridges may experience repeated errors during warm-up, requiring frequent replacements and potentially delaying test results.
Check the lot number on the cartridge; if it matches any of the listed numbers (251114J through 251231E), it is affected.
The recall does not specify a remedy, so you should contact GEM for guidance on next steps.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1530-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1530-2026 from GEM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
