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Biogenex Laboratories, Inc. recalls InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Recalled July 30, 2014 · FDA recall Z-2113-2014 · Biogenex Laboratories
Hazard
Product was distributed without 510(k) approval. · FDA Class II
Units
4 kits
Sold at
Brazil and Ecuador. No US distribution
Description
Product was distributed without 510(k) approval.
Product
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Manufacturer(s)
Biogenex Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →