Cell Marque Corporation
Cell Marque Corporation has 4 FDA enforcement events on this register (16 product records) between 2016 and 2021: 4 device; the busiest year was 2021 with 2.
0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 15 Jul 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 | Device | Class III | 1 | Ongoing |
| 27 May 2021 | Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798 | Device | Class II | 2 | Terminated |
| 5 May 2017 | Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent | Device | Class II | 12 | Terminated |
| 10 May 2016 | SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Cell Marque Corporation had?
4 enforcement events (16 product records) on this register, 2016–2021: 4 device.
Are any Cell Marque Corporation recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Cell Marque Corporation recalls?
3 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.