FDA-Device2015-05-06Class II
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.
Biocare Medical, LLC
Hazard
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Sold states
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.
Affected count
44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Manufactured in
4040 Pike Ln, Concord, CA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2015Don't want to check this manually?
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