Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors
The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical 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: FDA Class II recall with no reported illnesses or injuries. The cartridges may fail to detect dangerous low blood oxygen levels, potentially delaying critical treatment, meeting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Instrumentation Laboratory is recalling GEM Premier 3000 PAK blood gas analyzer cartridges. The recall affects approximately 2,448 units with specific part numbers and lot numbers that were distributed in Massachusetts, Minnesota, New York, and India.
Internal testing identified that the recalled cartridges may show incorrect oxygen levels when measuring low blood oxygen. Specifically, the cartridges may report oxygen levels as higher than they actually are in patients with very low blood oxygen (below 60 mmHg). These incorrect readings fall outside the manufacturer's labeled performance specifications. The positive bias in readings could result in failure to detect and adequately treat dangerously low blood oxygen (hypoxemia), potentially delaying critical medical treatment.
The manufacturer notes that standard quality control procedures for non-iQM GEM Premier 3000 analyzers may not detect this non-conformance. Facilities using these analyzers should check whether they have cartridges with any of the affected lot numbers and contact Instrumentation Laboratory for further guidance.
The recalled product
- Product
- GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
- 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. 00024307507: UDI-DI: 08426950087946
- Lot Numbers: 323031H
- 323531D
- 324231M
- 325031D
- 324931F
- 323831E
- 323031I
- 324231I
- 324831E
- 325631C
- Part No. 00024315007: UDI-DI: 08426950082484
- Lot Numbers: 323441B
- 323641G
- 323041H
- 323541D
- 324141J
- 324841E
- 325041D
- 325641C
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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