RecallDepth

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.

Company
Cell Marque Corporation
Recall Initiated
July 12, 2011
Posted
August 31, 2011
Terminated
August 31, 2011
Recall Number
Z-3110-2011
Quantity
2 units
Firm Location
Rocklin, CA

Reason for Recall

Incorrect label on product bottle, although labeling on outer box is correct.

Distribution

Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.

Lot / Code Info

Lot Number 1113202A, Exp date: 2014-04.

Root Cause

Labeling mix-ups

Action Taken

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.

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