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.
Recall
- Recall Number
- Z-1176-2012
- Event Number
- 61055
- Firm
- Cell Marque Corporation
- FEI Number
- 3000718726
- Product Code
- NJT
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- January 23, 2012
- Posted
- March 6, 2012
- Terminated
- October 19, 2012
- Address
- 6600 Sierra College Blvd, Rocklin, CA, 95677-4306
Description
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.
Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.
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 [email protected]. For questions regarding this recall call 1-800-665-7284 or 1-916-746-8900. .
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.
110 units