Medical Device Cartridges Recalled for Blood Oxygen Reading Errors
Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary 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 a risk-of-harm medical device with a known performance defect affecting critical patient measurements. While no illnesses or injuries have been reported, the defect poses a clear clinical risk by potentially masking dangerously low oxygen levels and delaying treatment of hypoxemia.
Plain-English summary
Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges used in blood gas analyzers. These cartridges measure blood oxygen levels (pO2) and other parameters in patient blood samples.
Internal testing identified that these cartridges may produce inaccurate readings when measuring low blood oxygen levels (below 60 mmHg). The cartridges exhibit a positive bias, meaning they tend to read higher than actual values. This measurement error exceeds the device's labeled performance specifications.
The primary clinical risk is that falsely elevated oxygen readings could prevent detection of low oxygen levels (hypoxemia) or interfere with adequate treatment. This may delay necessary clinical intervention. Additionally, the manufacturer's standard quality control procedures may not detect this defect in cartridges before they reach clinical use.
The recall affects specific lot numbers of cartridges distributed in Massachusetts, Minnesota, New York, and India.
The recalled product
- Product
- GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
- 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 (13)
- Part No. 00024307504: UDI-DI: 08426950087922
- Lot Numbers: 324230M
- 323630G
- Part No. 00024330004: UDI-DI: 08426950082507
- Lot Numbers: 325655C
- 322355C
- 323755H
- 323855E
- 326255D
- Part No. 00024345004: UDI-DI: 08426950082538
- Lot Numbers: 325660C
- 324160J
- 323760H
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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