Z-2481-2021Class II

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

Name: Z-2481-2021 BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Creator: Leica Microsystems, Inc.
Published: 2021-07-30
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2021-07-30 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 on 2021-07-30. FDA classified it as Class II and gives the reason as "Product may not perform as specified in IFU". 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-2481-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-30
Posted: 2021-09-16
Terminated: 2023-06-22
Recalling firm: Leica Microsystems, Inc.
Product: BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Product may not perform as specified in IFU.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: The firm notified their consignees by email on 07/30/2021. The notice explained the issue and requested destruction of the product.
Quantity in commerce: 237 units
Distribution: US Nationwide distribution.
Product codes and lots: Product Code PA0375, Lot 69909

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2481-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2481-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-16

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)