FDA-Device2021-04-21Class II
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Medline Industries Inc
Hazard
Possible false negative or false positive results due to the product being compromised during shipment.
Sold states
US Nationwide distribution in the state of Ohio.
Affected count
24 each
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2021Don't want to check this manually?
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