Z-1919-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2024
- Initiation Date
- April 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1160 devices
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
Reason for Recall
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Distribution Pattern
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.
Code Information
Lot Code: All Lots