Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0808-2016·Announced 2016-02-24

Leica Bond Polymer Refine Red Detection Kits Recalled for Staining Errors

Leica Microsystems is recalling Bond Polymer Refine Red Detection kits due to a manufacturing error that may cause inadequate staining.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a manufacturing error leading to inadequate staining (diagnostic error) rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or labeling/quality errors.

Plain-English summary

Leica Microsystems, Inc. is recalling 3,745 units of Bond Polymer Refine Red Detection DS9390 kits. The recall covers specific lot numbers including 41203, 41407, 41478, 41575, 41619, 41779, 41872, 42027, 42105, 42172, 42181, 42251, 42345, 42397, 42512, and 42594. These kits are intended for in vitro diagnostic use to detect tissue-bound antibodies on the BOND automated system.

The recall was initiated because a manufacturing error occurred during the filling of some containers. This error may result in inadequate staining, which could affect the accuracy of diagnostic results. The affected products were distributed nationwide in the United States and to various international locations, including Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan, Netherlands, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and the UK.

Users of these kits should stop using the affected lots and contact Leica Microsystems for further instructions or a replacement. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.

The recalled product

Product: Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system…
Manufacturer: Leica Microsystems, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: inadequate-staining
diagnostic-error
Affected units: 3,745

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

Product Code DS9390 with lot numbers 41203
41407
41478
41575
41619
41779
41872
42027
42105
42172
42181
42251
42345
42397
42512 and 42594.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Leica Microsystems, Inc.

See all →

High
Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
FDA (Devices) · 2022-12-21
High
Surgical microscope power supply may overheat and cause unexpected shutdown
FDA (Devices) · 2022-12-21
High
Leica Provido surgical microscope models at risk of unexpected power shutdown
FDA (Devices) · 2022-12-21
High
Leica Surgical Operating Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05
High
Leica M530 Surgical Microscopes recalled for illumination adjustment defect
FDA (Devices) · 2022-10-05

Same hazard · inadequate staining