FDA (Devices) recall action 88072
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Product distributed for use as an In-vitro Diagnostics without FDA clearance
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.
Cell Marque Corporation is recalling Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody because the product was distributed as an in-vitro diagnostic device without FDA clearance.