GEM recalls certain GEM Premier 5000 cartridges (GEM PAKs) that may repeatedly eject during warm-up, causing delays in test results. Affected units include specific part numbers and production lots.
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 GEM Premier 5000 cartridges (GEM PAKs) that may repeatedly eject during warm-up, causing test delays. This could require reinserting cartridges and potentially delaying patient results.
The GEM PAK cartridges may repeatedly eject during warm-up, causing the analyzer to show 'Process Control Solution Not Detected' errors. This can lead to test delays as the system may need to restart or reinsert cartridges.
Healthcare facilities using the GEM Premier 5000 blood analyzer with affected GEM PAK cartridges. Patients may experience delayed test results if the analyzer requires reinsertion of cartridges.
Check for part numbers 00055445010 or 00055445011 on the cartridge. Affected lots include specific production dates like 251023N through 251231Q.
Look for part numbers 00055445010 or 00055445011 on the GEM PAK cartridge.
No, the recall only affects specific GEM PAK cartridges. The analyzer can continue to be used with unaffected cartridges.
Check the part number on the cartridge. Affected models are part numbers 00055445010 or 00055445011 with specific production lots listed in the recall notice.
The recall does not indicate any risk of injury. The issue causes test delays but not physical harm.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1543-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1543-2026 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.
