FDA-Device2015-06-03Class III
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.
Biocare Medical, LLC
Hazard
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Sold states
Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
Affected count
19 units
Manufactured in
4040 Pike Ln, Concord, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1676-2015Don't want to check this manually?
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