Biocare Medical, LLC recalls CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information fo…

Recall date

March 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1535-2015

FDA classification

Class II

Brand / firm

Biocare Medical, LLC

Sold / distributed

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.

Why it was recalled

A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.