A Medical Device Daily

ThermoGenesis (Rancho Cordova, California) last week reported initiating a voluntary recall of certain lots of its AXP AutoXpress Platform (AXP) bag sets.

The company said it discovered in a document review process that some lots of the bag sets were distributed prior to the performance of pyrogen testing, a manufacturing release criterion.

The company’s website describes the AXP system as part of its cell therapy offerings: instrumentation for producing umbilical cord blood units, consisting of a battery-operated device, a processing set that has integrated sampling segments and GMP-compliant software.

The company said that this recall is not the result of any complaints or reports of patient safety issues and that the potential for any contamination is low. It said that AXP customers are being asked to return inventory from recalled lots for additional testing at ThermoGenesis and they may be required to perform an additional test before releasing a cord blood unit for transplant.

Thermogenesis said it is cooperating with the FDA and will provide updates concerning any new information, or if it sees any impact on company performance.

ThermoGenesis develops products and services that process, store, and administer doses of adult stem cells for treatment of disease and injury.