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Biocare Medical, LLC recalls CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic informati
Recalled May 6, 2015 · FDA recall Z-1535-2015 · Biocare Medical
Hazard
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. · FDA Class II
Units
44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Sold at
Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.
Description
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Product
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.
Manufacturer(s)
Biocare Medical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →