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FDAMay 20, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750007110

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110 — Recall Details · AllClear