Instrumentation Laboratory: Medical Device Recall in 2023 - (Recall #: Z-0359-2024)

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

Class II

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.

Part No. 00024315009: UDI-DI: 08426950082491, Lot Numbers: 323442F, 323142D, 323042K, 323142A, 323342K, 326142H, 323742C, 325442D, 325442E, 323042E, 324342A, 323042G, 323342H, 323542E, 324542A, 323542A, 324342B, 324042F, 323442H, 326442C, 325442F, 325942E, 326342B, 326142F, 325842C, 326442F; Part No. 00024330009: UDI-DI: 08426950082521, Lot Numbers: 323152A, 323152B, 324252B, 323552I, 323652I, 326152H, 323752B, 323352G, 323352H, 323052G, 323552A, 324352B, 324552A, 324052F, 323052E, 323352I, 323552F, 323352K, 325452F, 326352BC; Part No. 00024345009: UDI-DI: 08426950082552, Lot Numbers: 323462F, 323062K, 323162A, 323162C, 323562F, 323562I, 323662I, 323762D, 323762G, 323762J, 323862A, 323462C, 325762B, 323662D, 324462C, 324562A, 323362F, 325462F, 326362B; Part No. 00024360009: UDI-DI: 08426950082576, Lot Numbers: 323072J, 323072K, 323672I, 323772J, 324172D, 324372B, 323572A, 324072F, 325472F;

US States: MA, MN, NY. India.

Voluntary: Firm initiated