Medical device recalls Moderate risk

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

Recall date
May 27, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2106-2021
FDA classification
Class II
Brand / firm
Cell Marque Corporation
Sold / distributed
US: AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI OUS: N/A

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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