Z-1704-2016Class II

Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative...

Name: Z-1704-2016 Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative...
Creator: Leica Microsystems, Inc.
Published: 2016-03-22
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2016-03-22 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin... on 2016-03-22. FDA classified it as Class II and gives the reason as "Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining". 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-1704-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-22
Posted: 2016-05-21
Terminated: 2017-11-30
Recalling firm: Leica Microsystems, Inc.
Product: Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; [email protected]
Quantity in commerce: 290 units
Distribution: Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
Product codes and lots: Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1704-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1704-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-20

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)