Instrumentation Laboratory recalls GEM Premier 3000 PAKs with part numbers 00024307504, 00024330004, 00024345004 for potential false high oxygen readings that could delay hypoxemia treatment.
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges that may show falsely high oxygen levels in low ranges. This could lead to delayed treatment of low oxygen conditions, risking serious health consequences.
The recalled PAKs may show higher than actual oxygen levels (pO2) in the low range (below 60 mmHg). This false high reading could cause healthcare providers to miss low oxygen conditions, delaying critical treatment.
Healthcare facilities using the recalled GEM Premier 3000 PAK cartridges for blood gas analysis are most at risk. Patients receiving oxygen therapy could be affected if the device gives false high readings.
Check for part numbers 00024307504, 00024330004, or 00024345004 on the PAK cartridges. The lot numbers and UDI-DI codes listed in the recall notice also identify affected units.
Identify the part number on the PAK cartridge to see if it matches 00024307504, 00024330004, or 00024345004.
Internal testing found that the PAKs may show falsely high oxygen readings in low ranges, which could delay treatment of low oxygen conditions.
The false high readings might cause healthcare providers to miss low oxygen conditions, potentially delaying critical treatment.
Check the part number on the cartridge; affected units have part numbers 00024307504, 00024330004, or 00024345004.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-0357-2024 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0357-2024 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.
