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Mas Cardioimmune XL, Level 1, 2, 3 (2014-10-22)
- Starting date:
- October 22, 2014
- Posting date:
- November 4, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41995
Recalled Products
Mas Cardioimmune XL, Level 1, 2, 3
Reason
Customers reported vial-to-vial variation of B-type Natriuretic Peptide-32 (BNP-32) and Creatine Kinase-MB (CK-MB) recovery in Cardio Immune XL Level 1, part number CAI-XL 1, lot number CXL 16011. Within the same kit, some vials would recover consistently within the range of published value assignment, but other vials would recover dramatically outside the value assignment range (higher for BNP-32 and lower for CK-MB).
Affected products
Mas Cardioimmune XL, Level 1, 2, 3
Lot or serial number
CXL16011
Model or catalog number
CAI-XL1
Companies
- Manufacturer
-
Microgenics Corporation
46360 Fremont Blvd.
Fremont
94538
California
UNITED STATES