Z-1176-2012

Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle with screw cap lid...

Name: Z-1176-2012 Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle with screw cap lid...
Creator: Cell Marque Corporation
Published: 2012-01-23
License: https://open.fda.gov/license/

Cell Marque Corp. / initiated 2012-01-23 / Terminated / root cause: labeling and UDI

FDA source

Cell Marque Corporation began a recall of 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... on 2012-01-23. The reason FDA records is "Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1176-2012
Status: Terminated
Initiated: 2012-01-23
Posted: 2012-03-06
Terminated: 2012-10-19
Recalling firm: Cell Marque Corp.
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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.
Root cause tag: labeling and UDI
FDA 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 [email protected]. 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.
Product codes and lots: 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.

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)