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.
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: 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
Related recalls
Same manufacturer · Radiometer America Inc
See all →- HighRadiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities
FDA (Devices) · 2019-08-28
- HighRadiometer ABL800 FLEX Recalled for Underestimated Creatinine Measurements
FDA (Devices) · 2019-02-13
- HighRadiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch
FDA (Devices) · 2019-01-02
- ModerateRadiometer ABL90 FLEX Analyzers Recalled for Fluid Aspiration Error
FDA (Devices) · 2018-10-10
- HighRadiometer ABL800 Analyzer Recalled for Barcode Misinterpretation
FDA (Devices) · 2017-12-20
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighRadiometer AQURE System Software Recalled for Patient View Display Error
FDA (Devices) · 2016-12-28
- HighRadiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
- HighRadiometer AQURE Software Recalled for Potential Patient Data Mix-Up
FDA (Devices) · 2018-05-09
- SevereRadiometer AQURE basic system software recall for patient data mix-up risk
FDA (Devices) · 2020-02-05
- HighRadiometer ABL800 Analyzer Recalled for Barcode Misinterpretation
FDA (Devices) · 2017-12-20
- HighRadiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
FDA (Devices) · 2020-06-03