FDA recall Z-1675-2022

Ortho-Clinical Diagnostics, Inc. · Class II · device

Product

VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

Reason for recall

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

Key facts

Status: Ongoing
Initiation date: 2022-07-19
Report date: 2022-09-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1675-2022