California medical device maker Tandem Diabetes Care (NSDQ:TNDM) widened its insulin cartridge recall to include additional lots, sending shares down nearly 10% today.
Tandem’s recall originally affected insulin cartridges shipped from Dec. 17, 2013, through January 10, 2014, comprising more than 4,700 boxes of product. The recall now includes lots shipped prior to Oct. 16, 2013, representing a total of about 13,000 boxes of cartridges, the company said.
The news sent TNDM shares down to $25.02 as of about 12:50 p.m., down 7.2% on the day.
Tandem decided to pull the products after internal testing uncovered a leak risk that
could result in a dose of too much or too little insulin.
"The potential for a cartridge leak was identified during in-house product testing, and the cause has been identified," president & CEO Kim Blickenstaff said of the original recall. "Modifications to our cartridge manufacturing process have been implemented to prevent this issue from occurring in the future."
The company conducted additional testing after announcing the additional recall, Blickenstaff said in another statement issued yesterday.
"Based on this work we recognized that additional cartridge lots could also be at risk for leaking and so we are expanding the scope of this recall," he said. "We are confident that we have identified all of the affected cartridge lots that may have been shipped to customers or distributors and that we have implemented appropriate corrective actions to prevent this from happening in the future."
