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Biocare Medical, LLC recalls D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.:
Recalled June 3, 2015 · FDA recall Z-1676-2015 · Biocare Medical
Hazard
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. · FDA Class III
Units
19 units
Sold at
Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
Description
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Product
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.
Manufacturer(s)
Biocare Medical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →