Drug recall
MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers…
FDA recall event 82794 · Class II · Agilent Technologies, Inc.
Key facts
| Event ID | 82794 |
|---|---|
| Recall numbers | Z-2359-2019 |
| Recalling firm | Agilent Technologies, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the… |
| Initiation date | Aug 15, 2018 |
| Report date | Sep 4, 2019 |
| Termination date | Sep 28, 2021 |
| City | Santa Clara |
| State | CA |
| Country | United States |
| FEI number | 2916205 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: