Home / Recalls / Biocare Medical, LLC / Z-1676-2015

Z-1676-2015 Class III Terminated

Recalled by Biocare Medical, LLC — Concord, CA

Recall Details

Product Type
Devices
Report Date
June 3, 2015
Initiation Date
May 6, 2015
Termination Date
June 4, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Catalog number: PM266AA, lot 030615, Expiration: 2018/03.

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