CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryon...
FDA Device Recall #Z-0815-2016 — Class III — January 18, 2016
Recall Summary
| Recall Number | Z-0815-2016 |
| Classification | Class III — Low risk |
| Date Initiated | January 18, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lab Vision Corporation |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | RB-368-R7 - 30; RB-368-R1 -2 |
Product Description
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.
Reason for Recall
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Distribution Pattern
Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
Lot / Code Information
Product Code: RB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of July 2016. Product code: RB368-R1, Lot Number 368R1407B.
Other Recalls from Lab Vision Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0322-2016 | Class III | Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml... | Oct 27, 2015 |
| Z-0775-2014 | Class II | Estrogen Receptor AB-11 (Clone ID5) Mouse Mono... | Dec 6, 2013 |
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.