Z-1919-2024Class II

Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO...

Name: Z-1919-2024 Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO...
Creator: Agilent Technologies
Published: 2024-04-02
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2024-04-02 / Open, Classified / root cause: design

FDA source

Agilent Technologies began a recall of Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E... on 2024-04-02. FDA classified it as Class II and gives the reason as "There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1919-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-02
Posted: 2024-05-29
Recalling firm: Agilent Technologies, Inc.
Product: 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 Stainer IVD Component: N/A
Product code: KPA Slide Stainer, Automated
Reason for recall: There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Root cause tag: design
FDA root cause: Device Design
Action: On April 15, 2024, Agilent Technologies, issued a "Urgent Medical Device Correction" notification to affected consignees. Agilent asked consignees to take the following actions: 1. Monitor your device and contact the service organization in case you discover a problem with the plexiglass on the lower front door. - In case the plexiglass of the lower front door is broken, immediately cease operation of the instrument - Do not remove the lower front door assembly, and do not run the instrument without the cover2.Confirm that you have received this information by signing and returning enclosed acknowledgement form Agilent Agilent is currently improving the design of the assembly to correct the issue. When the new design becomes available, the Agilent Service Organization will contact you and update your device at the next service visit. Please document the information on the enclosed Acknowledgement Form and send to Agilent s Field Action Team at [email protected]. In case of any question, please contact your local sales representative or Agilent service organization. We kindly ask you to inform those who need to be aware of this notification within your organization or any other organization to which the affected product(s) have been transferred. Please ensure that your organization maintains awareness of this notice. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 1160 devices
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, Norway, Peru, South Korea, Sweden, Switzerland, Taiwan, The United Kingdom, Algeria, Bulgaria, Costa Rica, Cyrpus, Czech Republic, Ecuador, Egypt, Estonia, Greece, Hungary, India, Iraq, Ireland, Isreal, Kenya, Kuwait, Latvia, Lebanon, Morocco, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, Thailand, Turkey, Ukraine, United Arab Emirates, Vietnam.
Product codes and lots: Lot Code: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1919-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1919-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-05	2024-05-29

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)