Thermo Fisher Scientific (Asheville) LLC
Asheville, NC, US
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC appears in FDA device records in Asheville, NC. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 10 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 |
|---|---|---|---|---|---|
| 1036832 | 1036832 | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 275 Aiken Rd, ASHEVILLE, NC 28804 US | 2026 | |
| 1523845 | 1523845 | THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC | 401 MILLCREEK RD., MARIETTA, OH 45750 US | 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-1873-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1872-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1871-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1870-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1869-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1868-2019 | Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1867-2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1866-2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1865-2019 | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Class II | Terminated | |
| Z-1079-2013 | CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels. | Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain