Class II — Thermo Fisher Scientific (Monterrey)
| Recalling firm | THERMO FISHER SCIENTIFIC INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product was not irradiated; therefore, they are not sterile and do not meet product specification. |
| 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. |
| Quantity | 78,600 each (786 cartons, 100 devices/carton) |
| Distribution | US Distribution to states of: IL, KY , TX |
| Initiated | 2020-04-29 |
| Classified | 2020-05-26 |
| Terminated | 2020-12-10 |
| Recall number | Z-2126-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Thermo Fisher Scientific (Monterrey) (Z-2126-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85561/
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