Blood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings
Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall for measurement errors in blood gas analysis that could lead to missed or delayed treatment of hypoxemia. No illnesses or injuries have been reported, but the risk of harm is significant given the critical nature of oxygen level measurement in medical care.
Plain-English summary
Instrumentation Laboratory is recalling 2,448 units of GEM Premier 3000 PAK blood gas analyzer cartridges. These devices are used in hospitals and medical laboratories to measure blood oxygen levels (pO2) and other critical blood gases.
Internal testing identified that the cartridges may produce inaccurate, falsely elevated readings for blood oxygen levels in the critical low range (pO2 below 60 mmHg). These readings are outside the device's labeled performance specifications and may appear normal when actual oxygen levels are dangerously low.
Such measurement errors could lead medical professionals to miss or inadequately treat hypoxemia (low blood oxygen), resulting in delayed treatment. The standard quality control procedures in non-iQM GEM Premier 3000 systems may not detect these measurement errors.
The affected units are distributed in Massachusetts, Minnesota, and New York, as well as India. Affected lot numbers have been identified by the FDA.
The recalled product
- Product
- GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 2,448
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Instrumentation Laboratory
See all →- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- HighPortable Blood Analyzer System Recalled Due to Barcode Reader Misidentification Risk
FDA (Devices) · 2026-08-05
- HighBar Code Reader Wands for GEM Premier Blood Analyzers Recalled Due to Misidentification Risk
FDA (Devices) · 2026-08-05
- HighBlood Analyzer Bar Code Reader May Assign Patient Results to Incorrect Patient ID
FDA (Devices) · 2026-08-05
Same hazard · measurement error
See all →- HighPhilips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
FDA (Devices) · 2026-05-06
- ModeratePhilips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
FDA (Devices) · 2026-05-06
- ModeratePhilips MR 7700 MR Elastography device stiffness value error recall
FDA (Devices) · 2026-05-06
- ModeratePhilips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
FDA (Devices) · 2026-05-06
- ModeratePhilips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
FDA (Devices) · 2026-05-06