FDA-Device2020-07-08Class II
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
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
2617 units (U.S.=1272; OUS=1344)
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2020Don't want to check this manually?
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