---
title: "GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... — FDA record Z-0359-2024 | Is It on Recall"
description: "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 le"
url: https://isitonrecall.com/recall/fda-device-z-0359-2024-gem-premier-3000-pak-ph-pco2-po2-hct-na-k-ca-glucose-and-lactate-part-numbers-00024315009-0002433000/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009,... — FDA record Z-0359-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 29, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Instrumentation Laboratory
- **Quantity**: 2448 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0359-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0359-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US States: MA, MN, NY. India.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [New York](https://isitonrecall.com/state/new-york/)

## Dates in the source

- **Report date**: Nov 29, 2023
- **Recall initiation date**: Sep 29, 2023
- **Center classification date**: Nov 20, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0359-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Instrumentation Laboratory records](https://isitonrecall.com/brand/instrumentation-laboratory/)