RANCHO CORDOVA, Calif., Feb. 22 ThermoGenesisCorp.(Nasdaq: KOOL), said today that it has initiated a voluntary recall ofcertain lots of its AXP(TM) AutoXpress Platform(TM) (AXP) bag sets.
The Company said it has discovered in a document review process that somelots of the bag sets were distributed prior to the performance of pyrogentesting, which is a manufacturing release criterion.
The Company said that this recall is not the result of any customercomplaints or reports of patient safety issues. The Company also believesthat the potential for any contamination is low. What this means for AXPcustomers is they are being asked to return inventory from recalled lots foradditional testing at ThermoGenesis and they may be required to perform anadditional test before releasing a cord blood unit for transplant.
The Company is cooperating fully with the U.S. Food and DrugAdministration and will provide updates as new information becomes availableand if it believes there will be a potential material impact on the company'sperformance.
This press release, including statements regarding financial informationfor future periods, contain forward-looking statements, and such statementsare made pursuant to the safe harbour provisions of the Private SecuritiesLitigation Reform Act of 1995. These statements involve risks anduncertainties that could cause actual outcomes to differ materially from thosecontemplated by the forward-looking statements. Several factors, includingtiming of FDA approvals, changes in customer forecasts, our failure to meetcustomers' purchase order and quality requirements, supply shortages,production delays, changes in the markets for customers' products,introduction timing and acceptance of our new products scheduled for fiscalyear 2008, and introduction of competitive products and other factors beyondour control, could result in a materially different revenue outcome and/or inour failure to achieve the revenue levels we expect for fiscal 2008. A morecomplete description of these and other risks that could cause actual eventsto differ from the outcomes predicted by our forward looking statements is setforth under the caption "Risk Factors" in our annual report on Form 10-K andother reports we file with the Securities and Exchange Commission from time totime, and you should consider each of those factors when evaluating theforward looking statements.ThermoGenesis Corp. Web site: http://www.thermogenesis.com Contact: Investor Relations +1-916-858-5107, or [email protected]
SOURCE ThermoGenesis Corp.