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 and potentially delaying test results. This could affect lab operations and patient care timelines.
The recalled cartridges may cause repeated errors during warm-up, leading to the analyzer ejecting the cartridge and requiring a new one. This can prolong test turnaround times and potentially delay patient care.
Lab technicians using the GEM Premier 5000 blood analyzer with the recalled cartridges are most affected. Patients may experience delays in test results if the analyzer requires repeated cartridge replacements.
Check for the part number 00055415008 on the cartridge. The cartridges were sold with lots numbers starting with 251021P through 251229X.
Look for the lot numbers 251021P through 251229X on the cartridge packaging.
The recall is due to confirmed customer complaints that the cartridges may cause repeated errors during warm-up, requiring frequent replacements and potentially delaying test results.
Repeated cartridge ejections may prolong test turnaround times, requiring reassessment of patient management once results are available.
No, the recall does not require immediate discontinuation; the cartridges can continue to be used with monitoring for errors.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1534-2026 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.
