FDA-Device2018-03-21Class III
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Randox Laboratories
Hazard
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
Sold states
Distribution US nationwide.
Affected count
117 Kits
Manufactured in
515 Industrial Blvd, Kearneysville, WV, United States
Products
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0969-2018Don't want to check this manually?
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