Tandem Diabetes Care ($TNDM) is expanding a voluntary recall of specific lots of insulin cartridges used with its t:slim insulin pump. The cartridges may be at risk of leaking, resulting in over- or under-doses of insulin.
Tandem initially recalled more than 4,700 boxes of insulin cartridges for its t:slim pump on Jan. 10. The company performed further testing to determine whether additional lots contained leaks and decided to recall an aggregate 13,000 boxes of cartridges. The affected lots announced on Jan. 10 were shipped between Dec. 17, 2013, and Jan. 10, 2014, and the lots announced on Monday were shipped prior to Oct. 16, 2013.
The leakage was caused by a "specific piece of equipment" used in the cartridge test process, Tandem said in a statement. The company changed its cartridge test manufacturing process to prevent the issue from recurring.
"The safety of our customers is our top priority. For that reason, even after our previous announcement Tandem's team continued to perform further testing. 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," Tandem CEO Kim Blickenstaff said in a statement. "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."
The recall follows on the heels of the company's expansion efforts: Tandem collected $120 million in its IPO in November and said it would use $40 million of its earnings to increase marketing for its t:slim device. But the company took a $26.5 million loss in the first half of 2013 and said it would be a while before it turned a profit. T:slim accounts for approximately 93% of Tandem's sales.
Tandem is still evaluating whether additional cartridges in its internal inventory are usable. The company plans to replace affected cartridges free of charge and incur fees associated with shipping and recall coordination.
- read the company's statement here