FDA Medical Device Recalls (openFDA)
Cell Marque Corporation: 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 number
- Z-1176-2012
- Recalling firm
- Cell Marque Corporation
- 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.
- Status
- Terminated
- Initiated
- 2012-01-23
- Posted
- 2012-03-06
- Terminated
- 2012-10-19
- Reason
- Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3000718726
- Firm city
- Rocklin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28