Cell Marque Corporation FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16Class IIIJul 15, 2021Mouse Monoclonal Antibody labelled with an incorrect expiry	Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31	Class IIIDevices	Jul 15, 2021
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513Class IIMay 27, 2021Product distributed for use as an In-vitro Diagnostics with	Product distributed for use as an In-vitro Diagnostics without FDA clearance	Class IIDevices	May 27, 2021
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798Class IIMay 27, 2021Product distributed for use as an In-vitro Diagnostics with	Product distributed for use as an In-vitro Diagnostics without FDA clearance	Class IIDevices	May 27, 2021