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FDAMay 9, 2018device

VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic

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

The hazard

There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

261601654866261601654904261601654870261601654869261601655266261601655307261601655233261601655232261601655611261601655610261601655648261601655649

Recall history

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

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