FDA recall Z-2126-2020

Thermo Fisher Scientific (Monterrey) · Class II · device

Product

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.

Reason for recall

Product was not irradiated; therefore, they are not sterile and do not meet product specification.

Distribution

US Distribution to states of: IL, KY , TX

Key facts

Status
Terminated
Initiation date
2020-04-29
Report date
2020-06-03
Termination date
2020-12-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Apodaca Nuevo Leon 66600, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2126-2020