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U.S. Department of Health and Human Services

Class 3 Device Recall D240 (Lymphatic Marker)

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  Class 3 Device Recall D240 (Lymphatic Marker) see related information
Date Initiated by Firm May 06, 2015
Date Posted May 26, 2015
Recall Status1 Terminated 3 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 2		 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.
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