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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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