FDA-Device2022-03-02Class II
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The product was incorrectly shipped at room temperature rather than refrigerated.
Sold states
US Distribution was made to IL, FL, LA, MS, NC, OH, and TX.
Affected count
19 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2022Don't want to check this manually?
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