VITROS XT 3400 Chemistry System, Catalog No. 6844458
- Company
- Ortho-Clinical Diagnostics, Inc.
- Recall Initiated
- January 26, 2024
- Posted
- March 1, 2024
- Recall Number
- Z-1227-2024
- Quantity
- 7 US; 4 OUS
- Firm Location
- Rochester, NY
Reason for Recall
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.
Distribution
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.
Lot / Code Info
VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J34500940
Root Cause
Software Design Change
Action Taken
On January 26, 2024, the firm sent a customer letter to all customers who have V3.8.1 installed on their VITROS Analyzer. Customers were informed of this issue and instructed to follow the instructions when using the VITROS System onboard QC package to update the QC baseline. The software will be updated to mitigate both issues within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.