FDA Enforcement
Class II
Terminated
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.
Recall: Z-2126-2020
·
Reported June 3, 2020
Enforcement
- Recall Number
- Z-2126-2020
- Event ID
- 85561
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Thermo Fisher Scientific (Monterrey)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 3, 2020
- Initiation Date
- April 29, 2020
- Classification Date
- May 26, 2020
- Termination Date
- December 10, 2020
- Address
- Blvd Apodaca 500, Apodaca Technology Park, Apodaca Nuevo Leon 66600, N/A, N/A, Mexico
Description
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
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Code Info
Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4
Distribution
US Distribution to states of: IL, KY , TX
Quantity
78,600 each (786 cartons, 100 devices/carton)