Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0 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 Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Product Code: 6802783, UDI-DI: 10758750002979, Product Code: 6802914, UDI-DI: 10758750007103
Products Sold
Product Code: 6802783, UDI-DI: 10758750002979; Product Code: 6802914, UDI-DI: 10758750007103; Serial Numbers: J36000109 J36000294 J36001012 J36001489 J36000292 J36000340 J36001024 J36001495 J36000484 J36000348 J36001027 J36001513 J36000489 J36000446 J36001051 J36001515 J36000955 J36000511 J36001088 J36001519 J36001151 J36000517 J36001108 J36001528 J36001167 J36000580 J36001111 J36001535 J36001222 J36000688 J36001112 J36001570 J36001283 J36000753 J36001117 J36001573 J36001330 J36000861 J36001237 J36001575 J36001348 J36000877 J36001245 J36001579 J36000920 J36001246 J36001581 J36000923 J36001401 J36001582 J36000929 J36001403 J36001583 J36000933 J36001427 J36001600 J36000941 J36001451 J36001602 J36000942 J36001488 J36001618 J36001000
Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Runnin due to During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystem. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Recommended Action
Per FDA guidance
An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 10/10/23 was sent to customers. REQUIRED ACTIONS " Review the Customer Actions for the Condition Codes described in this notification. " Acknowledge your understanding of this notification by completing the enclosed Confirmation of Receipt form no later than October 18, 2023. " Save this notification with your User Documentation or post this notification by each VITROS 3600/4600/5600/XT 3400/XT 7600 System until this issue is resolved. " If your laboratory has experienced the issue described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization (Previously Ortho Care). Resolution QuidelOrtho is investigating root cause and will communicate again after root cause has been determined. A software update to address this issue is currently in development. Contact Information We apologize for any inconvenience this may cause your laboratory. If you have further questions, please contact our 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