Instrumentation Laboratory recalls GEM Premier 3000 PAKs with specific part numbers that may show false high oxygen levels in low ranges, risking delayed treatment of hypoxemia. Affected units include certain pH, pCO2, pO2, Hct, Na+, K+, Ca++ cartridges.
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 specific GEM Premier 3000 PAK cartridges that may show false high oxygen readings (pO2) at low levels. This could lead to delayed treatment of low oxygen conditions, which is serious for patients needing precise oxygen monitoring.
The recalled PAKs may show higher than actual oxygen levels (pO2) in the low range (below 60 mmHg). This false positive could lead to missing or delaying treatment for low oxygen conditions, which is critical for patient safety.
Healthcare providers using the GEM Premier 3000 PAK cartridges for blood gas analysis are most at risk. Patients with low oxygen levels may experience delayed treatment if the false high readings cause medical decisions to be made incorrectly.
Check the part numbers on the PAKs: 00024307507, 00024315007, 00024330007, 00024345007, or 00024360007. Also look for specific lot numbers listed in the recall notice for each part number.
Identify the part numbers on your GEM Premier 3000 PAKs to see if they match the recalled list: 00024307507, 00024315007, 00024330007, 00024345007, or 00024360007.
Check the lot numbers for each part number against the specific lists provided in the recall notice to confirm if your unit is affected.
Internal testing found that some GEM Premier 3000 PAKs may show false high oxygen readings (pO2) in low ranges, which could delay treatment for low oxygen conditions.
Using an affected PAK might cause false high oxygen readings at low levels (below 60 mmHg), which could lead to missing or delaying treatment for hypoxemia.
Check the part numbers on your PAK: 00024307507, 00024315007, 00024330007, 00024345007, or 00024360007. Also check the lot numbers listed for each part number in the recall notice.
We’ve drafted a message you can send Instrumentation Laboratory to request your refund or repair — edit it as you like.
Subject: Recall Z-0358-2024 — Instrumentation Laboratory Instrumentation Laboratory Hello, I own a Instrumentation Laboratory that is covered by recall Z-0358-2024 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.
