GEM recalls PAK cartridges for Premier 5000 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 specific PAK cartridges for its Premier 5000 device because they sometimes cause repeated errors during warm-up, which can lead to needing to replace the cartridge multiple times and delay test results. This affects lab equipment users who rely on the device for accurate testing.
The PAK cartridges may repeatedly fail to detect process control during warm-up, causing the device to eject the cartridge and require replacement. This can lead to longer wait times for test results and potential need for reassessment of patient management.
Lab technicians and healthcare facilities using the GEM Premier 5000 device with the recalled PAK cartridges. Those most at risk are users who rely on the device for frequent testing where repeated errors could delay critical results.
Check for the part number 00055360011 on the cartridge. The lot number 251119A and unique identifier 08426950807605 are also associated with this recall.
Look for the part number 00055360011, lot number 251119A, and unique identifier 08426950807605 on the cartridge.
The recall is due to confirmed customer complaints that the PAK cartridges may experience repeated process errors during warm-up, requiring frequent cartridge replacements and potentially delaying test results.
Repeated cartridge ejections during warm-up can prolong turnaround times, which may require reassessment of patient management once results are available.
No, the recall does not require stopping use; the cartridges can continue to be used but may need replacement more frequently.
We’ve drafted a message you can send GEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1527-2026 — GEM GEM Hello, I own a GEM that is covered by recall Z-1527-2026 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.
