Cell Marque Corporation

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2311-2021Class IIICell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16July 15, 2021
Z-2106-2021Class IICell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 008416831May 27, 2021
Z-2105-2021Class IICell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GMay 27, 2021
Z-2203-2017Class IIHer2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte SpeMay 5, 2017
Z-2208-2017Class IIVaricella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent InMay 5, 2017
Z-2201-2017Class IIEstrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent IMay 5, 2017
Z-2205-2017Class IIHerpes Simplex Virus I; 7.0 mL Catalog number 361A-18. Microbiology - Analyte Specific Reagent May 5, 2017
Z-2200-2017Class IIEstrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 MicrobiMay 5, 2017
Z-2210-2017Class IIHHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - AnaMay 5, 2017
Z-2209-2017Class IICD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - AnalMay 5, 2017
Z-2207-2017Class IISV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro May 5, 2017
Z-2202-2017Class IIH. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In May 5, 2017
Z-2204-2017Class IIHer2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog numbMay 5, 2017
Z-2206-2017Class IIHerpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . MicrobioloMay 5, 2017
Z-2199-2017Class IIAdenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 MicrobiMay 5, 2017
Z-2038-2016Class IISIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part May 10, 2016