Device recall: BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond…

Class II FDA enforcement event 84301. Recall start date: 18 Nov 2019. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Leica Microsystems, Inc. started this device recall on 18 Nov 2019. The firm address in the FDA record is in Buffalo Grove, IL. FDA put the recall in Class II. FDA event 84301 has 1 product record. The first FDA enforcement report date is 18 Dec 2019. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide and OUS to Canada.

Recalling firm

Leica Microsystems, Inc., Buffalo Grove, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 84301: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0673-2020	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…	558	Class II	Ongoing	18 Dec 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 33

Other events of the firm

Other FDA enforcement events of Leica Microsystems, Inc.
Initiated	Product (first record)	Type	Class	Records
21 Nov 2022	Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system	Device	Class II	3
26 Aug 2022	Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063	Device	Class II	4
3 Nov 2021	Leica Microsystems M220 F12 Microscope Systems	Device	Class II	1
30 Jul 2021	BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375	Device	Class II	1
20 May 2020	Leica ARveo and M530 OH6 microscope systems.	Device	Class II	1
3 May 2019	Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including i	Device	Class II	1
2 Jan 2019	Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the vis	Device	Class II	1
17 Sep 2018	BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments	Device	Class II	1
4 Sep 2018	Leica M525 F20 Surgical Microscope System	Device	Class II	1
4 Sep 2018	Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microsco	Device	Class II	1

Leica Microsystems, Inc.: all 33 events

Official channels

FDA enforcement report Z-0673-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 84301. https://recallregister.com/fda/ii/84301/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide and OUS to Canada.
What quantity of product is in FDA event 84301?: The FDA record gives this quantity: 558
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.