Instrumentation Laboratory recalls GEM Premier 3000 PAK cartridges with potential false high pO2 readings below 60 mmHg, which could delay hypoxemia treatment. Affected units include specific part numbers and lot numbers.
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 (pO2) in low ranges. This could cause delays in treating low oxygen levels, potentially harming patients. The recall affects specific part numbers and lot numbers.
The cartridges may show falsely high oxygen readings (pO2) when levels are below 60 mmHg. This could cause medical decisions to be made incorrectly, potentially delaying treatment for low oxygen levels and risking patient harm.
Healthcare facilities using the GEM Premier 3000 PAK cartridges with specific part numbers and lot numbers are most at risk. Patients receiving blood tests using these cartridges could be affected if the false readings delay oxygen treatment.
Check for part numbers 00024315009, 00024330009, 00024345009, or 00024360009. Look for specific lot numbers listed in the recall notice for each part number.
Identify your GEM Premier 3000 PAK part number and lot numbers to confirm if it is affected by this recall.
Internal testing found that some GEM Premier 3000 PAK cartridges may show falsely high oxygen readings (pO2) below 60 mmHg, which could delay treatment for low oxygen levels.
The recall does not include a remedy; you must check your product details to see if it is affected and contact the manufacturer for further instructions.
The recall states that false readings could delay treatment for low oxygen levels, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-0359-2024 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0359-2024 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.
