FEB 20, 2013
Mobius Therapeutics, the makers of Mitosol (mitomycin for solution) Kit for Ophthalmic Use, says the source for last month's voluntary recall was likely laboratory contamination induced at the time of testing. The company pulled two lots after lab tests indicated possible contamination with a strain of yeast on one or more parts in the kit.
"Upon investigation, we have determined conclusively that, during testing, a technician contaminated the sterility of the items that tested positive," said Ed Timm, president and CEO of Mobius. "As the Mobius investigation has determined that the contamination was induced post-sterilization, we now believe that this contamination was the likely source of the false positive result."
The testing procedure instructed sterile technicians to make physical contact with a non-sterile item (the outside of the sterile package) followed by immediate, consecutive contact with sterile kit components. By definition, this action contaminates the sterile components, making this action a likely source of organisms generating a false positive result.
"We are grateful to our testing laboratory for their exhaustive investigation," Timm continued. "While we had an inherent belief in the integrity of our processes, Mobius acted out of an abundance of caution in the interest of patient safety and worked with FDA in initiating a voluntary recall of the two lots in question."