Instrumentation Laboratory recalls GEM Premier 5000 cartridges with part number 00055415011 due to repeated process control errors during warm-up, potentially 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.
Instrumentation Laboratory is recalling GEM Premier 5000 cartridges that may cause repeated errors during warm-up, leading to the need to replace cartridges and possible delays in test results. This could affect healthcare facilities using these devices.
The GEM PAK cartridges may repeatedly eject during warm-up, causing the device to require new cartridges. This can lead to longer turnaround times for test results, potentially requiring reassessment of patient management.
Healthcare facilities using the GEM Premier 5000 device with the specified part number are most affected. Patients may experience delays in test results if the device requires repeated cartridge replacements.
Check for the part number 00055415011 on the GEM Premier 5000 cartridges. The lot number 251215D and unique device identifier 08426950807704 are also associated with this recall.
Verify the part number on the cartridge is 00055415011 to confirm if it is affected.
The recall is due to confirmed customer complaints about repeated process control errors during warm-up, which may cause the device to eject cartridges and require replacement.
Repeated cartridge ejections may delay test results, potentially requiring reassessment of patient management once results are available.
The official recall notice does not specify a remedy or action steps beyond checking the part number.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2026 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1536-2026 from Instrumentation Laboratory. 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.
