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Recall Observatory FDA recall evidence

Device product

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

Z-2481-2020

May 20, 2020

Class II

Product summary

Firm
Ortho Clinical Diagnostics
Event
Event 85762
Status
Terminated
Classification
Class II
Quantity
27 ( U.S.= 0; OUS= 27)
Official record key
device-enforcement:Z-2481-2020

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 : 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

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