GEM recalls specific PAK cartridges for the Premier 5000 that may cause repeated process errors during warm-up, requiring frequent cartridge replacements and potentially 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 certain PAK cartridges for the Premier 5000 that can cause repeated errors during warm-up, leading to frequent cartridge ejections and possible delays in test results. This issue may require more frequent cartridge replacements than usual, which could affect patient testing timelines.
The PAK cartridges may experience repeated errors during warm-up, causing the analyzer to eject the cartridge and require insertion of a new one. This can lead to longer turnaround times for test results, potentially requiring reassessment of patient management once results are available.
Healthcare facilities using the GEM Premier 5000 blood analyzer with the specific PAK cartridges listed in the recall. Laboratory staff and patients are most at risk of delayed test results due to repeated cartridge ejections.
Check for the part number 00055360004 on the cartridge. The lot numbers include 251113U, 251201AI, 251202Q, 251223E, 251223P, and 251229X. These cartridges were sold with the GEM Premier 5000 blood analyzer.
Verify the lot number on the cartridge to determine if it is affected by this recall.
If the cartridge is in the affected lot numbers, replace it with a new one from the manufacturer.
The recall is due to confirmed customer complaints that the PAK cartridges may experience repeated errors during warm-up, causing the analyzer to eject the cartridge and require frequent replacements.
Repeated cartridge ejections may prolong test turnaround times, potentially requiring reassessment of patient management once results are available.
Check the lot number on the cartridge to see if it is affected; if so, replace it with a new one from the manufacturer.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1524-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1524-2026 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.
