Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers US: J36001167 OUS: J36000427 J36001117 J36001558 J36000580 J36001154 J36001570 J36000626 J36001229 J36001573 J36000688 J36001427 J36001575 J36000877 J36001451 J36001579 J36000920 J36001488 J36001582 J36000929 J36001489 J36001583 J36000942 J36001495 J36001595 J36001012 J36001519 J36001602 J36001051 J36001528 J36001608 J36001108 J36001530 J36001632 J36001111 J36001535 J36001640
Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) due to A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026