Instrumentation Laboratory recalls GEM Premier 5000 cartridges (Part No. 00055445008) that may cause repeated errors during warm-up, requiring cartridge replacement and 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, requiring new cartridges and potentially delaying test results. This could affect lab testing accuracy and patient management.
The GEM PAK cartridges may experience repeated errors during warm-up, causing the system to eject the cartridge and require replacement. This can prolong testing times and potentially delay patient results if errors occur consecutively.
Lab technicians and healthcare facilities using the GEM Premier 5000 system with the specified cartridges. Those most at risk are labs handling high volumes of tests where repeated errors could delay results.
Check for the part number 00055445008 on the cartridge. The affected lots include 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, and 251215K.
Verify the lot number on the cartridge matches the affected lots listed: 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, or 251215K.
No, the recall does not require immediate discontinuation. The cartridges can continue to be used but may cause repeated errors during warm-up.
Check the lot number on the cartridge; affected lots include 251103J, 251110AF, 251111O, 251117AD, 251201AJ, 251202P, 251202Q, and 251215K.
Consecutive errors may delay results, but many cartridges continue to function normally. Labs should plan for potential disruptions.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2026 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-1542-2026 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.
