FDA-Device2020-06-03Class II
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
Thermo Fisher Scientific (Monterrey)
Hazard
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Sold states
US Distribution to states of: IL, KY , TX
Affected count
78,600 each (786 cartons, 100 devices/carton)
Manufactured in
Blvd Apodaca 500, Apodaca Technology Park, Apodaca Nuevo Leon 66600, N/A, Mexico
Products
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2126-2020Don't want to check this manually?
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