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.
|