Medical device recalls Moderate risk

Agilent Technologies recalls Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number:…

Recall date
April 2, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1919-2024
FDA classification
Class II
Brand / firm
Agilent Technologies
Sold / distributed
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, Norw…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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