Agilent MassHunter Software Recall Due to Sample Data Mismatch
Agilent Technologies is recalling MassHunter Quantitative Analysis Software versions B.07 or below due to a defect that causes sample name mismatches and prevents saving changes.
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, which typically corresponds to a moderate severity. The defect causes data display and saving errors but does not involve a direct physical hazard or reported injuries.
Plain-English summary
Agilent Technologies, Inc. is recalling MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers models K6460 and K6420. The recall affects 235 units distributed nationwide in the United States.
The recall is due to a software defect that occurs when using the 'Batch at a Glance' feature in the Compound Table view. When a new sample is inserted, the sample name becomes offset by one from the column header, creating a mismatch. Additionally, the Quant batch table will not display fully analyzed results or save any changes made.
Users of this software should discontinue using the affected workflow to generate reports. The recalling firm requests that users stop using this specific workflow to avoid data integrity issues.
The recalled product
- Product
- MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and…
- Manufacturer
- Agilent Technologies, Inc.
- Affected units
- 235
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)
- Software versions B.07 or below
Distribution
Distributed nationwide across the United States.
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