Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InSite HER-2 Detection Kit Recalled by Biogenex Laboratories, Inc. Due to Product was distributed without 510(k) approval.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biogenex Laboratories, Inc. directly.
Affected Products
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Quantity: 4 kits
Why Was This Recalled?
Product was distributed without 510(k) approval.
Where Was This Sold?
Brazil and Ecuador. No US distribution
About Biogenex Laboratories, Inc.
Biogenex Laboratories, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report