Recall Z-2106-2021— Cell Marque Corporation

Class II · Terminated

Class II FDA medical device recall by Cell Marque Corporation, initiated 2021-05-27, terminated 2024-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513. Reason: Product distributed for use as an In-vitro Diagnostics without FDA clearance.

Recalling firm
Cell Marque Corporation
Classification
Class II
Status
Terminated
Initiated
2021-05-27
Terminated
2024-04-05
Firm location
Rocklin, CA, United States

Product description

Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513

Reason for recall

Product distributed for use as an In-vitro Diagnostics without FDA clearance

Data sourced from openFDA. This site is unofficial and independent of the FDA.