Z-1877-2016Class II

Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in...

Name: Z-1877-2016 Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in...
Creator: Leica Microsystems, Inc.
Published: 2016-04-05
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2016-04-05 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues on 2016-04-05. FDA classified it as Class II and gives the reason as "Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1877-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-05
Posted: 2016-06-01
Terminated: 2017-11-30
Recalling firm: Leica Microsystems, Inc.
Product: Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent: Medical Device Recall Notification dated 4/5/2016 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent Complete the attached Recall Notification Acknowledgement Form that this action has been undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to [email protected] to receive credit for affected lots that have been destroyed by the consignees laboratory.
Quantity in commerce: 90 Units
Distribution: Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Product codes and lots: 1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1877-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1876-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01
Z-1877-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01

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)