Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System (New and Refurbished) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103, Serial Numbers: J36001164 through J36001692 (inclusive).
Products Sold
Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).
Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System (New and Refurbished) due to Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Recommended Action
Per FDA guidance
An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 01/22/24 was sent to customers. REQUIRED ACTIONS: To reduce the risk of unintended sample aspiration, refer to the procedure provided in this notification titled, Temporary TRAY Loading Instructions . QuidelOrtho recognizes that the Temporary TRAY Loading Instructions procedure may not be tenable for all laboratories due to testing volumes. Review your laboratory risk management plan(s) to assess the need for this further mitigation. Acknowledge your understanding of this notification by completing the enclosed Confirmation of Receipt form no later than January 30, 2024. Save this notification with your User Documentation or post this notification by each VITROS 3600/5600/XT 7600 System until this issue has been resolved. If your laboratory has experienced the anomaly described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization (formerly Ortho Care). QuidelOrtho has identified root cause however, our investigation is still ongoing. We are currently working on a Hardware Modification (MOD) to resolve this issue and will communicate again once the MOD or additional information is available. Current estimated availability date of the MOD is 2nd quarter 2024. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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