Medical Device Safety and Recalls: Richard-Allan Scientific, 10% Neutral Buffered Formalin

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Richard-Allan Scientific, 10% Neutral Buffered Formalin

A recall has been issued for the Richard-Allan Scientific, 10% Neutral Buffered Formalin.  Richard-Allan Scientific discovered that the defective products returned from several customers were found to have from 0% to 3% Formalin content instead of the required 10%.  A too-low or too high concentration of Formalin will not properly preserve or can damage tissues.  Use of this defective Formalin may prevent or delay diagnoses and treatment decisions. The long-range health impact can include death or disability from a disease, such as cancer, that was not correctly diagnosed or treated, or an injury from using a treatment that may not have been needed.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm421411.htm

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