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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Recall: BioArchive (Vapor Bypass Assembly)-Thermogenesis Corporation

DATE RECALL INITIATED:

May 7, 2008

PRODUCT:

BioArchive Vapor Bypass Assembly (110v / 220v)

MANUFACTURER:

Thermogenesis Corporation
Rancho Cordova, CA

REASON:

The BioArchive system is a computer-controlled, robotic liquid nitrogen cryopreservation and storage system that enables the freezing and managing of blood component samples. It has been discovered that a connector type on the Controller Box for the Vapor Bypass Assembly allows for possible connection to an incorrect power source that can create the risk of electrical shock. The nature of the shock is wall current and voltage of 100v or 220v depending on the facility. A replacement Controller Box for the Vapor Bypass Assembly has been designed and will be ready to ship as a direct replacement within one month of this notice.

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448