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U.S. Department of Health and Human Services

Class 2 Device Recall Cell Marque CD7 (MRQ12);

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  Class 2 Device Recall Cell Marque CD7 (MRQ12); see related information
Date Initiated by Firm January 23, 2012
Date Posted March 06, 2012
Recall Status1 Terminated 3 on October 19, 2012
Recall Number Z-1176-2012
Recall Event ID 61055
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
Product Cell Marque CD7 (MRQ-12);
Mouse Monoclonal Antibody,
Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label.
Cell Marque, Rocklin, CA 95677,

intended for qualified laboratories to qualitatively identify by light microscopy, the presence of associated antigens in section of formalin fixed, paraffin embedded tissue section 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 or physician.
Code Information Catalog numbers: 107M-14 (0.1 ml concentrate); 107M-15 (0.5 ml concentrate); 107M-16 (1.0 ml concentrate); 107M-17 - (1.0 ml predilute) and 107M-18 (7.0 ml predilute). Product lot # 8109, Exp 2012-09.
Recalling Firm/
Manufacturer		 Cell Marque Corporation
6600 Sierra College Blvd
Rocklin CA 95677-4306
For Additional Information Contact Veronica Runyan
916-746-8977
Manufacturer Reason
for Recall		 Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Cell Marque sent a Field Notification letter dated January 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and return the attached form indicating they have received the notification. Customers were also asked to destroy any existing inventory of the affected product. If the product was shipped to their customers, customers should confirm that they have contacted those customers. Customers were asked to complete, sign and date and return the attached Acknowledgement Form by faxing it to 1-916-746-8989 or by scanning it and emailing it to bdevos@cellmarque.com. For questions regarding this recall call 1-800-665-7284 or 1-916-746-8900. .
Quantity in Commerce 110 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Greece, Turkey, Italy, The Netherlands, Spain, Portugal, France, Israel, S. Korea, Pakistan, Morocco, Russia and Brazil.
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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