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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
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