Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number
Summary
The FDA issued a Class II for Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer by Agilent Technologies. Reason: There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury..
Details
Source
Device Recall
External ID
Z-1919-2024
Action Date
2024-06-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: All Lots
Quantity Affected: 1160 devices
Reason for Recall
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, 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-02
Company
Loveland, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Agilent Technologies) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Agilent Technologies have FDA actions?
This is the only FDA action we have on record for Agilent Technologies in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1919-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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