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Device Recall ThermoFisher/Microgenics
Model / Serial
Catalog number, Lot Numbers & Expiration Dates: CAI-XLL, CXL1301L, 31 JAN 2013; CAI-XL1, CXL13011, 31 JAN 2013; CAI-XL2, CXL13012, 31 JAN 2013; CAI-XL3, CXL13013, 31 JAN 2013; CAI-XL4, CXL13014, 31 JAN 2013; CAI-XLS, CXL1301S, 31 JAN 2013
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Worldwide, including Germany, France, Italy and Spain.
Product Description
ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. || Catalog Numbers & Description: || CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; || CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;
Manufacturer
Microgenics Corporation
1 Event
Recall of Device Recall ThermoFisher/Microgenics
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Manufacturer
Microgenics Corporation
Manufacturer Address
Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
Manufacturer Parent Company (2017)
Thermo Fisher Scientific Inc
Source
USFDA
Language
English
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