GEM recalls specific PAK cartridges for the Premier 5000 that may cause repeated errors during warm-up, leading to ejections and delays in test results. Affected units include certain lot numbers and part numbers.
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 the Premier 5000 that can cause repeated errors during warm-up, leading to the cartridge being ejected and requiring replacement. This may delay test results and require reassessment of patient management.
The PAK cartridges may experience repeated errors during warm-up, causing the system to eject the cartridge and require insertion of a new one. This can prolong test turnaround times and potentially delay patient care.
Healthcare facilities using the GEM Premier 5000 with affected PAK cartridges (part number 00055360008) are most at risk. Patients may experience delays in test results if the issue occurs.
Check for the part number 00055360008 on the cartridge. Affected units include specific lot numbers: 251021P, 251113U, 251117AD, 251204T, 251222U, 251223E, 251229AG, 251229X.
Verify the part number on the cartridge is 00055360008.
The recall is due to confirmed customer complaints that affected PAK cartridges may experience repeated errors during warm-up, causing the cartridge to be ejected and requiring replacement.
The system may eject the cartridge and require insertion of a new one, which can prolong test turnaround times and potentially delay patient care.
Check the part number on the cartridge; affected units have part number 00055360008 and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1525-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1525-2026 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.
