GEM recalls specific GEM Premier 5000 cartridges that may cause repeated errors during warm-up, leading to ejections and delays in test results. Affected units include certain lots and part numbers.
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 cartridges for the GEM Premier 5000 lab equipment because they can cause repeated errors during warm-up, leading to the cartridge being ejected and requiring replacement. This may delay test results and require reassessment of patient management.
The cartridges may cause repeated errors during warm-up, leading to the cartridge being ejected and requiring insertion of a new one. This can prolong test turnaround times and potentially delay patient results, requiring reassessment once results are available.
Laboratory users with the specific GEM Premier 5000 equipment and the listed cartridge lots are affected. Patients may experience delays in test results if the equipment requires repeated cartridge replacements.
Check if your GEM Premier 5000 equipment has the part number 00055415005 and the listed lots: 251125S, 251201AJ, 251212O, 251218V, or 251229X.
Verify your cartridge's lot number against the affected lots listed: 251125S, 251201AJ, 251212O, 251218V, or 251229X.
The recall is due to confirmed customer complaints that specific GEM Premier 5000 cartridges may cause repeated errors during warm-up, leading to ejections and requiring replacement.
The cartridge may be ejected during warm-up, requiring insertion of a new cartridge. This can prolong test turnaround times and potentially delay patient results.
No, the equipment can continue to be used, but affected cartridges should be checked against the listed lots to ensure they are not part of 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-1533-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1533-2026 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.
