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.
Z-2126-2020
Product summary
- Event
- Event 85561
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78,600 each (786 cartons, 100 devices/carton)
- Official record key
device-enforcement:Z-2126-2020
Official wording
Reason: Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Code information: Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4
Distribution pattern: US Distribution to states of: IL, KY , TX
Derived failure modes
-
Unknown
Product was not irradiated; therefore, they are not sterile and do not meet product specification.