Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for u...

FDA Device Recall #Z-1876-2016 — Class II — April 5, 2016

Recall Summary

Recall Number Z-1876-2016
Classification Class II — Moderate risk
Date Initiated April 5, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Leica Microsystems, Inc.
Location Buffalo Grove, IL
Product Type Devices
Quantity 270 units

Product Description

Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

Reason for Recall

Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.

Distribution Pattern

Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.

Lot / Code Information

1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.

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.