Z-0673-2020Class II

BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use...

Name: Z-0673-2020 BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use...
Creator: Leica Microsystems, Inc.
Published: 2019-11-18
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2019-11-18 / Open, Classified / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free... on 2019-11-18. FDA classified it as Class II and gives the reason as "BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0673-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-11-18
Posted: 2019-12-12
Recalling firm: Leica Microsystems, Inc.
Product: BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Customers were notified with an Urgent Medical Device recall letter beginning 11/18/2019. The letter identified affected product, stated reason for recall, requested that product not be used and to dispose of any product on hand. A response form was asked to be completed and returned. Questions can be directed to Adam Blunier at 1-847-821-3462 or [email protected].
Quantity in commerce: 558
Distribution: Nationwide and OUS to Canada.
Product codes and lots: Lot: 65549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0673-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0673-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-12

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)