PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 28, 2021 Initiated: May 27, 2021 #Z-2106-2021

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

Details

Recalling Firm
Cell Marque Corporation
Units Affected
2 units
Distribution
US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A
Location
Rocklin, CA

Frequently Asked Questions

What product was recalled?
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513. Recalled by Cell Marque Corporation. Units affected: 2 units.
Why was this product recalled?
Product distributed for use as an In-vitro Diagnostics without FDA clearance
Which agency issued this recall?
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2106-2021.