FDA-Device2020-07-08Class II

VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

Ortho Clinical Diagnostics
Hazard

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

Sold states
US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
Affected count
27 ( U.S.= 0; OUS= 27)
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2481-2020

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