Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GEM Premier 3000 PAK - pH Recalled by Instrumentation Laboratory Due to Internal testing identified that the GEM Premier PAKs...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentation Laboratory directly.
Affected Products
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Quantity: 2448 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: MA, MN, NY
About Instrumentation Laboratory
Instrumentation Laboratory has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report