Thermo Fisher Bacterial Test Recall Now Deemed Class I
The FDA issued an update on Remel’s Oct. 20 recall of Thermo Fisher Scientific Gram Negative IVD AST Sensititre Plates, deeming it a Class 1 recall because of the risk of serious injury or death from potential false results.
The in vitro diagnostic test assesses the susceptibility of Gram-negative organisms towards certain antibiotics, enabling physicians to select appropriate treatments for infected patients.
A false susceptibility result could lead patients to receive an ineffective treatment and experience serious injury or health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death, the agency said.
The 18,906 affected products were distributed between Jan. 26, 2021, and Oct. 16. The FDA has received five Medical Device Reports concerning the recalled products but no reports of injuries or deaths.