FDA-Device2022-09-21Class III
BIOPHEN UFH Control Plasma
Aniara Diagnostica LLC
Hazard
Incorrect product labeling was included in the package.
Sold states
Distribution in US - IL and MI
Affected count
13 units (1 unit is 1 box)
Manufactured in
7768 Service Center Dr, West Chester, OH, United States
Products
BIOPHEN UFH Control Plasma
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2022Don't want to check this manually?
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