Devices

Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO

Model / Serial
MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014. MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
Product Description
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; || Liquid Assayed Integrated Immunoassay Control. || Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. || .
Manufacturer
Microgenics Corporation
1 Event
- Recall of Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO

Manufacturer

Microgenics Corporation

Manufacturer Address
Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
Manufacturer Parent Company (2017)
Thermo Fisher Scientific Inc
Source
USFDA

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