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Formalin, Neutral Buffered

FDA product code IFP · Class 1 · Pathology

111
Registered devices
39
Adverse events
2
Recalls
15
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2016-06-13Richard-Allan Scientific Companypotential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will a
2008-05-01ThermoFisher Scientific Co., LLCAssay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.