GEM recalls specific Premier 5000 PAK cartridges that may cause repeated errors during warm-up, potentially delaying test results. Affected units include certain lot numbers from 2025-2026.
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 blood analyzer that may cause repeated errors during warm-up, leading to test delays. This could require retesting and reassessment of patient care if errors occur consecutively.
The PAK cartridges may experience repeated 'Process Control Solution Not Detected' errors during warm-up, causing the machine to eject the cartridge and require replacement. This can prolong test turnaround times and potentially delay patient care if errors occur consecutively.
Healthcare facilities using the GEM Premier 5000 blood analyzer with affected PAK cartridges (part numbers listed) are most at risk. Patients may experience delays in test results if consecutive errors occur.
Check for the part number 00055407508 on the cartridge. Affected lots include 251021P through 260102F, produced between late 2025 and early 2026.
Look for the lot numbers listed in the recall notice (251021P through 260102F) on the cartridge.
No, the recall does not require immediate discontinuation. The issue may occur but does not cause immediate harm.
Consecutive errors may delay results, requiring retesting and patient reassessment if errors occur repeatedly during warm-up.
Check the lot number on the cartridge. If it matches the affected lots listed, 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-1529-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1529-2026 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.
