MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical ...
FDA Device Recall #Z-0501-2015 — Class II — October 20, 2014
Recall Summary
| Recall Number | Z-0501-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 20, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Microgenics Corporation |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 2135 vials. |
Product Description
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
Reason for Recall
MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
Lot / Code Information
Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.
Other Recalls from Microgenics Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0415-2026 | Class II | Thermo scientific MAS Omni CARDIO, Liquid Assay... | Oct 1, 2025 |
| Z-1284-2022 | Class II | QMS Tacrolimus Immunoassay REF 10015573 CALIBRA... | Jan 20, 2022 |
| Z-0008-2017 | Class II | Thermo Scientific QMS Everolimus Assay; Model ... | Aug 15, 2016 |
| Z-2884-2016 | Class II | DRI Salicylate Serum Tox Assay, Catalog number ... | Jul 25, 2016 |
| Z-1930-2014 | Class III | MAS Omni Immune PRO Controls | Dec 2, 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.