FDAFDA · Food and drugs·Recall number Z-0501-2015
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.
Published December 10, 2014 · Recall initiated: October 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microgenics Corporation
- Distributor
- 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
- Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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