Z-1226-2024 Class II Ongoing
FDA device recall Z-1226-2024 was initiated by Ortho-Clinical Diagnostics, Inc. on Jan 26, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 30 US: 38 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Jan 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 US: 38 OUS
Product Description
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
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 Pattern
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.
Code Information
VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers US: J56001885 J56003484 J56001886 J56003541 J56001910 J56003570 J56002308 J56003583 J56002461 J56003646 J56002474 J56003669 J56002608 J56003670 J56002698 J56004068 J56002704 J56004137 J56003342 J56004174 J56003356 J56004491 J56003377 J56004506 J56003433 J56004549 J56003477 J56004551 J56003478 J56004577 OUS: J56000425 J56002518 J56000512 J56002615 J56000533 J56002625 J56000674 J56002637 J56000680 J56002926 J56000719 J56002929 J56000809 J56003061 J56000831 J56003260 J56000836 J56003285 J56001051 J56003401 J56001111 J56003464 J56001114 J56003508 J56001208 J56003523 J56001731 J56003538 J56001765 J56004346 J56001826 J56004355 J56001853 J56004415 J56002085 J56004531 J56002116 J56004695
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1226-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026