FDA Device recall Z-2126-2020
Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for tempo…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for tempo… by Thermo Fisher Scientific Monterrey, citing product was not irradiated; therefore, they are not sterile and do not meet product specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2126-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-29 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Thermo Fisher Scientific Monterrey |
| Distribution | IL, KY, TX |
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
Product was not irradiated; therefore, they are not sterile and do not meet product specification.
Identifiers
| code_info | Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2126-2020%22
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