Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCELL MARQUE CORPORATION
United States·US-MF-000028332
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 6600, Sierra College Blvd, Rocklin, United States
- Website
- cellmarque.com
- —
- —
- [email protected]
- Phone
- +1 916 746 8900
- PRRC Contact
- Cheryl Prichard
- EUDAMED SRN
- US-MF-000028332
- FDA FEI Number
- 3017212430
- DUNS Number
- 025048773
Catalogue (2151)
Page 44 of 44| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cytokeratin (OSCAR) Mouse Monoclonal Antibody | 300M-15 | EUDAMEDFDA UDI | Class C | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (18)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 15, 2021 | Z-2311-2021 | — | open, classified | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest. |
| May 27, 2021 | Z-2105-2021 | — | terminated | Product distributed for use as an In-vitro Diagnostics without FDA clearance |
| May 27, 2021 | Z-2106-2021 | — | terminated | Product distributed for use as an In-vitro Diagnostics without FDA clearance |
| May 5, 2017 | Z-2204-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2209-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2203-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2199-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2200-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2205-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2202-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2201-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2207-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2206-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2210-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 5, 2017 | Z-2208-2017 | — | terminated | Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act. |
| May 10, 2016 | Z-2038-2016 | — | terminated | Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result. |
| Jan 23, 2012 | Z-1176-2012 | — | terminated | Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2. |
| Jul 12, 2011 | Z-3110-2011 | — | terminated | Incorrect label on product bottle, although labeling on outer box is correct. |