Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Merck KGaALabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Merck KGaA group view.
As of Nov 15, 2026, FDA's public records list Cell Marque with 16 device recalls. The most recent is a device recall dated Jul 15, 2021: Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 15, 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16Class III · Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. | Device recalls |
| May 27, 2021 | Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513Class II · Product distributed for use as an In-vitro Diagnostics without FDA clearance | Device recalls |
| May 27, 2021 | Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798Class II · Product distributed for use as an In-vitro Diagnostics without FDA clearance | Device recalls |
| May 5, 2017 | HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostClass II · Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the | Device recalls |
| May 5, 2017 | H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Class II · Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the | Device recalls |
| May 5, 2017 | Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte SpecificClass II · Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the | Device recalls |
| May 5, 2017 | Herpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte SpecifClass II · Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the | Device recalls |
| May 5, 2017 | Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte SpecClass II · Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
