Instrumentation Laboratory: Medical Device Recall in 2023 - (Recall #: Z-0357-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

Product Classification:

Class II

Date Initiated: September 29, 2023

Date Posted: November 29, 2023

Recall Number: Z-0357-2024

Event ID: 93313

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.

Status: Ongoing

Product Quantity: 2448 total

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

Distribution Pattern:

US States: MA, MN, NY. India.

Voluntary or Mandated:

Voluntary: Firm initiated