USFDA Medical Device Recall Alert : Richard-Allan Scientific, 10% Neutral Buffered Formalin - May Contain Incorrect Concentration of Formalin

Recall Class: Class I

Date Recall Initiated: September 17, 2014

Products: 10% Neutral Buffered Formalin.

All other lots not included the table below, or similar products manufactured by Richard-Allan Scientific, are not affected by this recall.

Manufacturing Date: July 18, 2014, Distribution Dates: July 18 - September 17, 2014

Use: 10% neutral buffered Formalin is a liquid chemical used to preserve human tissue samples. These tissues are later examined for changes that could be caused by specific conditions or diseases, including cancer. The primary users of this solution are doctors’ offices, clinics, hospital emergency departments, and operating rooms.

Recalling Firm: 

Richard-Allan Scientific, subsidiary of Thermo Fisher Scientific

4481 Campus Drive

Kalamazoo, Michigan 49008

Reason for Recall: 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.