Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CD99 Catalog number PM008 AA Recalled by Biocare Medical, LLC Due to A drop in staining intensity over time has...
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 Biocare Medical, LLC directly.
Affected Products
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
Quantity: 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Why Was This Recalled?
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Biocare Medical, LLC
Biocare Medical, LLC has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report