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Type of Product
Medical Device
TGA Recall Reference
RC-2014-RN-01122-1
Product Name/Description
Thermo Scientific MAS CardioImmune XL
Catalogue Number: CAI-XL1
Lot Number: CXL16011
Expiration Date: 31/01/2016
Recall Action Level
Hospital
Recall Action Classification
Class II
Recall Action Commencement Date
28/10/2014
Responsible Entity
Thermo Fisher Scientific
Reason/Issue
Due to a manufacturing production error, 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).
Recall Action
Recall
Recall Action Instructions
Contact Information