Richard-Allan Scientific, a subsidiary of Thermo Fisher Scientific, recalled various 10% neutral buffered Formalin products after discovering that the defective products returned from several customers were found to have from 0% to 3% Formalin content instead of the required 10%, according to the FDA.
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, the FDA explained on their website.
Richard-Allan Scientific sent an Urgent Medical Device Recall letter dated Sept. 10, to all customers followed by a second letter dated Oct. 3, with additional information.
The firm sent a follow-up letter dated Oct. 10, 2014 that recommended attending physicians of all patients that could be affected be contacted in order to determine if further testing is required for their patients.