Thermo Fisher Scientific (Monterrey)
Apodaca Nuevo Leon, MX
Thermo Fisher Scientific (Monterrey) appears in FDA device records in Apodaca Nuevo Leon, MX. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3023443877 | 3023443877 | Thermo Fisher Scientific (Monterrey) | Carretera Miguel Aleman Km 21, Apodaca Nuevo Leon 66600 MX | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing. | Product was not irradiated; therefore, they are not sterile and do not meet product specification. | Class II | Terminated | |
| Z-0273-2020 | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905 | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial | Class II | Terminated | |
| Z-0272-2020 | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904 | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain