GEM recalls specific PAK cartridges for the Premier 5000 that may cause repeated process errors during warm-up, leading to ejections and delays in 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 may cause repeated errors during warm-up, requiring the cartridge to be replaced. This can delay test results and potentially require reassessment of patient management.
The recalled PAK cartridges may cause repeated errors during warm-up, leading to the cartridge being ejected and requiring replacement. This can prolong test turnaround times and potentially delay patient care.
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 issue occurs.
Check for the part number 00055415004 on the cartridge. The lot numbers listed in the recall include 251111O through 251230P.
Identify the lot number on the cartridge to determine if it is in the recalled list (251111O, 251112P, 251113U, etc.).
The recall is due to confirmed customer complaints that the PAK cartridges may experience repeated errors during warm-up, causing ejections and requiring replacement.
The cartridge may be ejected and require replacement, which can prolong test turnaround times and potentially delay patient care.
Check the lot number on the cartridge; recalled lots include 251111O, 251112P, 251113U, and other specific numbers listed in the recall.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1532-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
