Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system ...

FDA Device Recall #Z-0808-2016 — Class II — November 27, 2015

Recall Summary

Recall Number Z-0808-2016
Classification Class II — Moderate risk
Date Initiated November 27, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leica Microsystems, Inc.
Location Buffalo Grove, IL
Product Type Devices
Quantity 3745

Product Description

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 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.

Reason for Recall

The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : 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 UK.

Lot / Code Information

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

Other Recalls from Leica Microsystems, Inc.

Recall # Classification Product Date
Z-0477-2023 Class II Leica MICROSYSTEMS M530 OHX, Part Number 104487... Nov 21, 2022
Z-0476-2023 Class II Leica MICROSYSTEMS Provido, Part Numbers 104489... Nov 21, 2022
Z-0475-2023 Class II Leica MICROSYSTEMS Proveo 8, Part Number 104490... Nov 21, 2022
Z-1849-2022 Class II Leica Surgical Operating Microscopes, Arveo, Pa... Aug 26, 2022
Z-1848-2022 Class II Leica Surgical Operating Microscopes, ARveo 8, ... Aug 26, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.