Z-0501-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2014
- Initiation Date
- October 20, 2014
- Termination Date
- March 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.