GEM recalls specific GEM Premier 5000 cartridges that may cause repeated 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 reassessment of patient management.
The recalled cartridges may experience repeated errors during warm-up, causing the analyzer to eject the cartridge and require replacement. This can lead to longer turnaround times and potential delays in patient care.
Users of the GEM Premier 5000 blood analyzer with specific cartridge lots are affected. Laboratories using these cartridges are most at risk of delays in test results.
Check the cartridge lot numbers listed: 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251201AJ, 251202P, 251203Q, 251208AA, 251212O, 251215J, 251216K, 251217I, 251217J, 251218V, 251219R, 251222T, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P.
Identify the lot number on the cartridge to see if it matches the listed lots: 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251201AJ, 251202P, 251203Q, 251208AA, 251212O, 251215J, 251216K, 251217I, 251217J, 251218V, 251219R, 251222T, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P.
The recalled cartridges may experience repeated errors during warm-up, causing the analyzer to eject the cartridge and require replacement, which can delay test results.
Check the cartridge lot number against the list: 251111O, 251113U, 251117AD, 251118D, 251119D, 251120X, 251124Z, 251125S, 251201AI, 251201AJ, 251202P, 251203Q, 251208AA, 251212O, 251215J, 251216K, 251217I, 251217J, 251218V, 251219R, 251222T, 251222U, 251223E, 251223P, 251229AG, 251229X, 251230P.
No, the recall does not require stopping use. The cartridges may continue to work but can cause repeated errors and delays.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1537-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1537-2026 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.
