Class 3 Device Recall D240 (Lymphatic Marker)

• Date Initiated by Firm: May 06, 2015
• Date Posted: May 26, 2015
• Recall Status: Terminated on June 04, 2015
• Recall Number: Z-1676-2015
• Recall Event ID: 71229
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• 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.
• Code Information: Catalog number: PM266AA, lot 030615, Expiration: 2018/03.
• Recalling Firm/ Manufacturer: Biocare Medical, LLC; 4040 Pike Ln; Concord CA 94520-1227
• For Additional Information Contact: Scott Huntsman; 925-603-8033
• Manufacturer Reason for Recall: Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
• FDA Determined Cause: Labeling mix-ups
• Action: Biocare Medical sent a Medical Device Notification letter dated May 6, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete all actions listed on the enclosed Return Response Form.
• Quantity in Commerce: 19 units
• Distribution: Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.