Santa Clara, CA, United States
Agilent Technologies, Inc. recalls
4 recalls recorded since 2018, most recently on 20 March 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 March 2025
- Reason
- DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.
- Distribution
- US distribution to the state of: MA and OUS (International) distribution to countries of: Spain, Italy, Japan, Colombia, Poland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1544-2025
- GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
Ongoing Class II Medical devices
- Recall started
- 2 April 2024
- Reason
- There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, TN, MI, MD, MA, OR, AK, MO, NC, NH, GA, RI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Spain, Italy, Japan, Malaysia, Netherland, New Zealand, Nor
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1919-2024
- Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide
Ongoing Class III Medical devices
- Recall started
- 20 May 2022
- Reason
- Label provided for substrate vail contained incorrect expiration date.
- Distribution
- U.S. Nationwide distribution in the states of NY and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1384-2022
- Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
Terminated Class II Medical devices
- Recall started
- 15 August 2018
- Terminated
- 28 September 2021
- Reason
- 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 sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made.
- Distribution
- US Nationwide. distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2359-2019
- 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 identif
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.