Z-1053-2012

Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal...

Name: Z-1053-2012 Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal...
Creator: Leica Microsystems, Inc.
Published: 2012-01-10
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2012-01-10 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the... on 2012-01-10. The reason FDA records is "The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated". 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-1053-2012
Status: Terminated
Initiated: 2012-01-10
Posted: 2012-02-17
Terminated: 2012-04-18
Recalling firm: Leica Microsystems, Inc.
Product: Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. PA0266; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. For the qualitative identification by light microscopy of CD7 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Leica Microsystems, Inc. sent a Medical Device Field Notification letter dated January 4, 2012, via first class mail on January 10, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the product and to return the product to the firm. Customers who have received the affected lot numbers of the listed products were requested to return any unused/part used reagents to the Buffalo Grove, IL, location for replacement. The accounts were asked to complete the attached Acknowledgement Form, acknowledging receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the account's Leica Representative. For further questions please call (847) 405-0123
Quantity in commerce: 139 - 7 mL vials
Distribution: Worldwide Distribution -- USA (nationwide) and the country of Canada.
Product codes and lots: Catalog No. PA0266, lot numbers 10604 and 13566

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)