Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro d...
FDA Device Recall #Z-3126-2017 — Class II — July 14, 2017
Recall Summary
| Recall Number | Z-3126-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Leica Biosystems Richmond Inc. |
| Location | Richmond, IL |
| Product Type | Devices |
| Quantity | 37 |
Product Description
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing..
Reason for Recall
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Distribution Pattern
Nationwide Distribution to AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MI, MN, NC, NH, NV, NY, OR, PA, SC, TN, TX, VA, and WI.
Lot / Code Information
Product Code PA0813, Lot No. 47800, Exp. Date 09/24/2019
Other Recalls from Leica Biosystems Richmond Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3125-2017 | Class II | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA08... | Jul 14, 2017 |
| Z-3121-2017 | Class II | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF P... | Jul 14, 2017 |
| Z-3120-2017 | Class II | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF ... | Jul 14, 2017 |
| Z-3124-2017 | Class II | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF ... | Jul 14, 2017 |
| Z-3123-2017 | Class II | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, ... | Jul 14, 2017 |
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.