FDA-Device2022-04-20Class II
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The product was stored incorrectly due to improper storage controls which may lead to delayed results.
Sold states
Distribution was made to AL, FL, NE OH, TX, WA, and WI. There was no foreign/military/government distribution.
Affected count
10 boxes
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0933-2022Don't want to check this manually?
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