Devices

Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

Model / Serial
Lot 1320, Product code: 6800035 and 6800040
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
Product Description
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 || VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS
1 Event
- Recall of Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS

Manufacturer Address
ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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