COMPANY RECEIVES WARNING LETTER AFTER ISSUING RECALL

The FDA learned through Hardy Diagnostics' recent voluntary recall of its HardyCHROM O157 device that the company was marketing the device without approval, an agency warning letter said.

The device is a culture agent in a Petri dish that is selective for the bacteria E. coli O157. Hardy initiated the recall following customer complaints that the selective agent lost potency as it neared the end of its shelf life, becoming less selective for E. coli O157.

The HardyCHROM O157 is adulterated because it lacks an approved application for premarket approval or an approved application for an investigational device exemption, according to the Jan. 8 letter, which was posted to the FDA website Jan. 16.

The device is also misbranded because Hardy did not notify the FDA of its intent to commercially distribute the device, the agency said. (http://www.fdanews.com/ddl/34_5/)