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VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Run...

FDA Recall #Z-0543-2024 — Class II — October 10, 2023

Recall #Z-0543-2024 Date: October 10, 2023 Classification: Class II Status: Ongoing

Product Description

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0

Reason for Recall

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.

Recalling Firm

Ortho-Clinical Diagnostics, Inc. — Rochester, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

63 units

Distribution

US Nationwide. Global Distribution.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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