Richard-Allan Scientific of Kalamazoo, Michigan, discovered that 10% neutral buffered Formalin returned from several customers had 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 tissue samples.
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.
Use of the 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.
The affected product was manufactured on July 18, 2014, and distributed from July 18 through September 17, 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
See also Medical Law Perspectives, October 2012 Report: Mistakes in Diagnosing Cancer: Liability Concerns for Misdiagnosis, Failure to Diagnose, and Delayed Diagnosis