FDA · Medical device recall

VITROS 3600 Immunodiagnostic System (New and Refurbished) and 2 more products

March 13, 2024 Class II

Date: March 13, 2024
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: Ortho-Clinical Diagnostics, Inc.
Reason: 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.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

3 products in this recall

VITROS 3600 Immunodiagnostic System (New and Refurbished)

Product: VITROS 3600 Immunodiagnostic System (New and Refurbished)
Quantity: 489 units (46 US, 443 OUS)
Codes and lots: Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).
Recall started: Jan. 22, 2024
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Component change control
What the company told customers: 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.
Recall number: Z-1220-2024

VITROS 5600 Integrated System (New and Refurbished)

Product: VITROS 5600 Integrated System (New and Refurbished)
Quantity: 1460 units (506 US, 954 OUS)
Codes and lots: UDI/DI: (New) 10758750002740, (Refurbished) 10758750007110; Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive).
Recall started: Jan. 22, 2024
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Component change control
What the company told customers: 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.
Recall number: Z-1221-2024

VITROS XT7600 Integrated System

Product: VITROS XT7600 Integrated System
Quantity: 1,720 units (834 US, 886 OUS)
Codes and lots: Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).
Recall started: Jan. 22, 2024
Device type: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Root cause (FDA): Component change control
What the company told customers: 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.
Recall number: Z-1222-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1220-2024, Z-1221-2024, Z-1222-2024. The agency record governs; check it and the company before acting.

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