GEM recalls Premier 5000 machines with specific model numbers due to GEM PAK cartridges causing repeated errors during warm-up, 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 specific models of its Premier 5000 blood analyzers because their GEM PAK cartridges can cause repeated errors during warm-up. This may lead to delays in test results and require reinserting cartridges, but does not pose an immediate safety risk.
GEM PAK cartridges for the Premier 5000 can cause repeated 'Process Control Solution Not Detected' errors during warm-up, leading to the machine ejecting the cartridge and requiring reinsertion. This may prolong test turnaround times and require reassessment of patient management once results are available.
Laboratories using GEM Premier 5000 analyzers with the specified model numbers are most affected. Patients may experience delays in test results if the machine requires reinserting cartridges.
Check your Premier 5000 machine's model number (00055430010) and lot numbers listed in the recall notice. The affected units have specific production dates and batch codes.
Verify your Premier 5000 machine's model number matches the recalled units (00055430010).
Watch for repeated 'Process Control Solution Not Detected' errors during warm-up cycles.
No, the recall does not require immediate discontinuation. Laboratories can continue using the machine with monitoring for errors.
Check your machine's model number and lot numbers against the list provided in the recall notice.
Yes, repeated errors may delay results and require reinsertion of cartridges, but the machine remains safe to use.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1539-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1539-2026 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.
