GEM recalls specific PAK cartridges for the Premier 5000 that may cause repeated errors during warm-up, potentially delaying test results. Affected units include Part No. 00055407511 with lots 251114K, 251201X, 251215D.
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, leading to test delays. This issue affects lab equipment used in medical testing environments where consistent results are critical.
The PAK cartridges may repeatedly eject during warm-up, causing the system to require new cartridges. This can delay test results and require reassessment of patient management. However, the issue does not cause physical harm or equipment damage.
Healthcare facilities using the GEM Premier 5000 blood analyzer with the specific PAK cartridges listed. Labs that handle blood tests are most at risk due to potential delays in patient results.
Check for the part number 00055407511 on the cartridge. Affected lots include 251114K, 251201X, and 251215D. The recall applies to GEM Premier 5000 systems sold with these specific cartridges.
Identify the lot number on the cartridge to see if it matches 251114K, 251201X, or 251215D.
No, the recall does not require immediate discontinuation. The issue may cause delays but does not pose a safety risk.
Consecutive errors may delay results, requiring reassessment of patient management once results are available. This is a temporary operational issue.
The recall does not specify a remedy, so contact GEM directly for guidance on next steps.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1531-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1531-2026 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.
