Radiometer AQURE System Recalled for Sample Type Design Error
Radiometer America Inc is recalling 375 AQURE Systems (Model 933-599) because a design error may leave the sample type field blank, potentially leading to misinterpretation of blood gas and immunoassay results.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Radiometer America Inc is recalling 375 units of the AQURE System, Model Number 933-599, Version 1.8.3. The AQURE System is a medical device used to manage blood gas and immunoassay analyzers. The recall was initiated due to a design error regarding the specification of sample types.
The defect causes the sample type field to be left blank for some results, while it is specified for others. The recall notice states that this inconsistency could lead to the misinterpretation of results. The affected units were distributed worldwide, including in the United States and numerous international locations.
Consumers and healthcare facilities should contact Radiometer America Inc for further instructions regarding the recall. No specific instructions for immediate disposal or cessation of use are provided in the source text beyond the recall notification.
The recalled product
- Product
- AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
- Manufacturer
- Radiometer America Inc
- Affected units
- 375
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)
- Model Number: 933-599 Version 1.8.3
Distribution
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