Radiometer AutoCheck5+ Level 2 Quality Control Ampoules Recalled for Inaccurate Results
Radiometer America is recalling AutoCheck5+ Level 2 quality control ampoules because they may provide incorrect pCO2 and pO2 results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inaccurate quality control results rather than direct patient injury or a high-risk pathogen, fitting the Moderate criteria for low-risk contamination or labeling issues.
Plain-English summary
Radiometer America Inc is recalling 1,669 boxes of AutoCheck5+, Level 2 quality control (QC) ampoules. These products are specifically designed for use with Radiometer America blood gas analyzers. The recall involves Lot R0698, Code S7745.
The recall was initiated because a few of the ampoules may provide incorrect results for pCO2 and pO2. Defective ampoules may yield pCO2 results close to or just outside the low end of the control range (4.92–5.85 kPa or 36.9–46.9 mmHg) and pO2 results considerably higher than the expected assigned value of 13.9–14.3 kPa (104–107 mmHg).
The affected products were distributed worldwide, including the United States, Canada, and numerous international locations. Users should stop using the affected ampoules and contact Radiometer America for further instructions.
The recalled product
- Product
- AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
- Manufacturer
- Radiometer America Inc
- Category
- Medical Device — Quality Control
- Hazard
- Affected units
- 1,669
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 (1)
- S7745 Lot R0698
Distribution
Distributed nationwide across the United States.
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