# FDA recall Z-0357-2024

> **Instrumentation Laboratory** · Class II · device recall initiated 2023-09-29.

## Product

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

US States: MA, MN, NY. India.

## Key facts

- **Recall number:** Z-0357-2024
- **Recalling firm:** Instrumentation Laboratory
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-29
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bedford, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2024

## Citation

> AI Analytics. FDA recall Z-0357-2024. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-0357-2024. Source: US FDA. Licensed CC0.

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