GEM recalls specific GEM Premier 5000 cartridges that may cause repeated process errors during warm-up, requiring frequent cartridge replacements and 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 GEM Premier 5000 cartridges that may cause repeated errors during warm-up, requiring frequent cartridge replacements. This can delay test results and may require reassessing patient management once results are available.
The recalled cartridges may cause repeated errors during warm-up, leading to the equipment ejecting the cartridge and requiring a new one. This can prolong test turnaround times and potentially delay patient results.
Healthcare facilities using the GEM Premier 5000 with the recalled cartridges are most affected. Patients may experience delayed test results if the equipment requires frequent cartridge replacements.
Check for the part number 00055445004 on the GEM Premier 5000 cartridges. The lot numbers include 251111O, 251117AD, 251124Z, and other specific codes listed in the recall notice.
Review the lot numbers on the cartridge to see if they match the recalled list: 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T, 251208AA, 251212O, 251216K, 251217I, 251223E, 251229AG, 251229X, 251230P.
No, the recall does not require stopping use; the equipment can continue to be used with non-recalled cartridges.
Check the lot number on the cartridge against the list: 251111O, 251117AD, 251124Z, 251125S, 251202P, 251204T, 251208AA, 251212O, 251216K, 251217I, 251223E, 251229AG, 251229X, 251230P.
Yes, repeated errors may delay test results and require 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-1541-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1541-2026 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.
