Biocare Medical, LLC recalls D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a m…

Recall date

May 6, 2015

Source

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

Recall number

Z-1676-2015

FDA classification

Class III

Brand / firm

Biocare Medical, LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.

Why it was recalled

Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.