Recall Z-1221-2024

Reason for recall

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.

FDA-determined cause: Component change control

Action taken

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.