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ThermoGenesis Says FDA Concurs with Plan for Previously Announced AXP(TM) Bagset Recall
Date:2/26/2009

RANCHO CORDOVA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- ThermoGenesis, Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that the FDA has agreed with its plan to remedy the voluntary recall of certain lots of AXP disposable bagsets that it announced in November.

At that time, the Company had indicated that the recall was not the result of any safety issues; the field action was a result of the potential for particulates to be released into the sterile, non-pyrogenic fluid path as a result of a defective component provided by one of the suppliers to the Company. The Company indicated that it was providing customers a blood filter to be used, as necessary, with any bags that had already been processed.

"We are pleased with the decision by the FDA regarding our remediation effort to address this issue," said Matthew Plavan, Chief Executive Officer. "As we indicated at the time we announced the recall, we believed that the $520,000 we had reserved to cover any costs related to this recall would be sufficient, and in fact, we may be able to recoup some of that reserve going forward," he added.

"We appreciate the support we have received from our customers during this period," he continued.

About ThermoGenesis Corp.

ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These products include:

  • The BioArchive(R) System, an automated cryogenic device, is used by cord blood stem cell banks in more than 25 countries
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SOURCE ThermoGenesis Corp.
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