FDA-Device2021-12-29Class II
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Sold states
US Nationwide distribution in the states of IL, OH, MS, and PA.
Affected count
14 units (individual)
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0404-2022Don't want to check this manually?
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