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U.S. Department of Health and Human Services

Class 3 Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody.

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  Class 3 Device Recall CD99 (H0361.1) Mouse Monoclonal Antibody. see related information
Date Initiated by Firm July 12, 2011
Date Posted August 31, 2011
Recall Status1 Terminated 3 on August 31, 2011
Recall Number Z-3110-2011
Recall Event ID 59436
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Cell Marque antibody CD99 (H036-1.1)
Mouse Monoclonal Antibody.
Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677

The Cell Marque CD99 Mouse Monoclonal Antibody is intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in sections of formalin fixed, paraffin embedded tissue sections using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient's clinical history and other diagnostic tests evaluated by a qualified pathologist of physician.
Code Information Lot Number 1113202A, Exp date: 2014-04.
Recalling Firm/
Manufacturer		 Cell Marque Corporation
6600 Sierra College Blvd
Rocklin CA 95677
For Additional Information Contact Veronica Runyan
916-746-8977
Manufacturer Reason
for Recall		 Incorrect label on product bottle, although labeling on outer box is correct.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Cell Marque, notified customers by telephone on July 12, 2011. The customers were instructed to return the product. Cell Marque immediately issued replacement of the product. If you have any further question or require additional documentation, contact the VP of Regulatory and Quality Affairs at (916) 746-8900.
Quantity in Commerce 2 units
Distribution Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
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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