Device 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
Z-1919-2024
Product summary
- Event
- Event 94439
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1160 devices
- Official record key
device-enforcement:Z-1919-2024
Official wording
Reason: There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
Code information: Lot Code: All Lots
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.
Derived failure modes
-
Unknown
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.