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Recall Observatory FDA recall evidence

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

April 02, 2024

Class II

Product summary

Firm
Agilent Technologies
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

    reason.no_named_rule · v1.0.0

    There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.