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Recall Observatory FDA recall evidence

Device product

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

Z-2483-2020

May 20, 2020

Class II

Product summary

Firm
Ortho Clinical Diagnostics
Event
Event 85762
Status
Terminated
Classification
Class II
Quantity
130 units (U.S.=57; OUS=73)
Official record key
device-enforcement:Z-2483-2020

Official wording

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

Code information: 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

Distribution pattern: US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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