FDA-Device2020-07-08Class II
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
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
130 units (U.S.=57; OUS=73)
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2483-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief