FDA-Device2024-03-13Class II
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Ortho-Clinical Diagnostics, Inc.
Hazard
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Sold states
Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
Affected count
4 US; 18 OUS
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1225-2024Don'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