Z-0357-2024 Class II Ongoing
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 total
Product Description
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
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. 00024307504: UDI-DI: 08426950087922, Lot Numbers: 324230M, 323630G; Part No. 00024330004: UDI-DI: 08426950082507, Lot Numbers: 325655C, 322355C, 323755H, 323855E, 326255D; Part No. 00024345004: UDI-DI: 08426950082538, Lot Numbers: 325660C, 324160J, 323760H