Z-3110-2011

Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard...

Name: Z-3110-2011 Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard...
Creator: Cell Marque Corporation
Published: 2011-07-12
License: https://open.fda.gov/license/

Cell Marque Corp. / initiated 2011-07-12 / Terminated / root cause: labeling and UDI

FDA source

Cell Marque Corporation began a recall of Cell Marque antibody CD99 (H036-1.1) Mouse Monoclonal Antibody. Cel Marque, 6600 Sierra College Boulevard, Rocklin, Ca 95677 The Cell Marque CD99 Mouse... on 2011-07-12. The reason FDA records is "Incorrect label on product bottle, although labeling on outer box is correct". 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-3110-2011
Status: Terminated
Initiated: 2011-07-12
Posted: 2011-08-31
Terminated: 2011-08-31
Recalling firm: Cell Marque Corp.
Product: 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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Incorrect label on product bottle, although labeling on outer box is correct.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 2 units
Distribution: Worldwide distribution: USA (nationwide) include state of : CA and country of: Great Britain.
Product codes and lots: Lot Number 1113202A, Exp date: 2014-04.

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)