Samco Bio-Tite Sterile Specimen Container — Class II medical device recall Z-2126-2020
Terminated recall by Thermo Fisher Scientific (Monterrey), reported 2020-06-03, distributed in IL, KY, TX. Product was not irradiated; therefore, they are not sterile and do not meet product specification.
| Recall number | Z-2126-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermo Fisher Scientific (Monterrey), Apodaca Nuevo Leon 66600, N/A, Mexico |
| Recall initiated | 2020-04-29 |
| Classified | 2020-05-26 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2020-12-10 |
| Distributed | IL, KY, TX |
| Reason classes | sterility |
| Lot numbers | 1270428 |
| Model numbers | 0006 |
| Expiration dates | 2021-11-19 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2126-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.