Product Safety Recalls

Product Recall Tracker

Ortho-Clinical Diagnostics, Inc. Recall 90681

Description: VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

Ortho-Clinical Diagnostics, Inc. Recall 90681 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1676-2022
Event ID90681
Event DescriptionVITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Product TypeDevices
DistributionWorldwide 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.
Quantity1148 units
Recall ReasonPerforming 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.
Device Classification20220914
Device Code InfoUDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer
Center Classification Date20220902
Recall Initiation Date20220719
Recalling FirmOrtho-Clinical Diagnostics, Inc.
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.