Z-0359-2024 Class II Ongoing
FDA device recall Z-0359-2024 was initiated by Instrumentation Laboratory on September 29, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 2448 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2448 units
Product Description
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Reason for Recall
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.
Distribution Pattern
US States: MA, MN, NY. India.
Code Information
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;