Recall Register

Food, drugs, devices › Firms

Agilent Technologies, Inc.

FDA recalling firm · 4 enforcement events · 4 product records · 2015–2025 · CA

Agilent Technologies, Inc. has 4 FDA enforcement events on this register (4 product records) between 2015 and 2025: 4 device; the busiest year was 2015 with 1.

0% of its events are Class I; the most common class is Class II (3). 2 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
20 Mar 2025GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).DeviceClass II1Ongoing
20 May 2022Kit 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 K589911-21512DeviceClass III1Ongoing
15 Aug 2018MassHunter 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 drugs) in human specimens by ionizing the…DeviceClass II1Terminated
17 Jun 2015Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in…DeviceClass II1Terminated

By type and class

Device4
Class II3
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Agilent Technologies, Inc. by year initiated.

Questions and answers

How many FDA recalls has Agilent Technologies, Inc. had?

4 enforcement events (4 product records) on this register, 2015–2025: 4 device.

Are any Agilent Technologies, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Agilent Technologies, Inc. recalls?

3 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.