GEM recalls specific Premier 5000 PAK cartridges that may cause repeated errors during warm-up, delaying test results. Affected units may require frequent cartridge replacements.
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 certain Premier 5000 PAK cartridges that can cause repeated errors during warm-up, leading to delays in test results. This may require inserting new cartridges more often than usual, potentially affecting patient care timelines.
The recalled PAK cartridges may cause repeated 'Process Control Solution Not Detected' errors during warm-up. This can lead to the analyzer ejecting the cartridge multiple times, requiring frequent replacements and potentially delaying test results.
Healthcare facilities using the GEM Premier 5000 blood analyzer with the recalled PAK cartridges are most affected. Patients may experience delays in test results if the analyzer requires frequent cartridge replacements.
Check for the part number 00055407504 on the cartridge. Affected lots include 251111O through 251231F (as listed in the recall notice).
Identify the lot code on the cartridge to determine if it is affected.
Reach out to GEM for guidance on handling affected cartridges or potential replacements.
No, the recall does not require immediate discontinuation. The issue may be managed with routine cartridge replacement.
Check the lot code on the cartridge; affected lots are listed in the recall notice (251111O through 251231F).
Yes, repeated errors may delay test results, requiring reassessment of patient management once results are available.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1528-2026 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.
