Ortho Clinical Diagnostics: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

Agency Publication Date: July 1, 2020

Affected Products

Product: VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

Affected Serial Number Range: J36000109-J36001317

Product: VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

Affected Serial Number : 36000192 36000396 36000430 36000431 36000446 36000468 36000504 36000517 36000577 36000580 36000585 36000631 36000647 36000366 36000267 36000386 36000404 36000420 36000562 36000614 36000575 36000589 36000480 36000582 36000687 36000492 36001042

Product: VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740

Affected Serial Number Range : J56000114- J56001879

Product: VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110

Affected Serial Number: 56001535 56001152 56001641 56001437 56000786 56000255 56001235 56001280 56001724 56001062 56000308 56001347 56001184 56000315 56003277 56001352 56000458 56001570 56000825 56000261 56001182 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56000843 56001264

Product: VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610

Affected Serial Number Range: J76000111-J76000525

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85762

Status: Resolved

Manufacturer: Ortho Clinical Diagnostics

Manufactured In: United States

Units Affected: 5 products (779 (U.S.= 225;OUS= 554); 27 ( U.S.= 0; OUS= 27); 2617 units (U.S.=1272; OUS=1344); 130 units (U.S.=57; OUS=73); Total= 353 ( U.S.= 167; OUS 186))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.