Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) s...
FDA Device Recall #Z-1315-2015 — Class II — December 16, 2014
Recall Summary
| Recall Number | Z-1315-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 16, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Leica Microsystems, Inc. |
| Location | Buffalo Grove, IL |
| Product Type | Devices |
| Quantity | 309 units |
Product Description
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist.
Reason for Recall
The staining intensity decreases over the shelf life.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, CT, FL, IA, ID, IL, MT, NC, NY, TX, WA and in the countries of: Argentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Denmark, El Salvador, France, Germany, Hungary, India, Italy, Japan, Netherlands, Nigeria, Portugal, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom.
Lot / Code Information
Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: Lot 6022274, Expiry 2015-04; Lot 6024628, Expiry 2015-08; Lot 6030581, Expiry 2016-07
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.