Fast-breaking News from AABB PulsePoints The following has been reproduced from the October 20, 2005 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

October 20, 2005
No. 719

CBER Announces Additional Recalls of Human Tissue Products

AABB PulsePoints

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), on Oct. 13, 2005, announced a recall of Human Tissue for Transplantation.  Biomedical Tissue Services (BTS), located in Fort Lee, N.J., manufactures this product.

According to the recall notice, BTS "was recently made aware that there is the possibility that tissue has been procured from donors without proper medical/social histories."

To view CBER’s recall notice, visit: www.fda.gov/cber/recalls/btstis101305.htm.

Additional facilities announcing recalls of tissue received from BTS are:

Regeneration Technologies, Inc., in Alachua, Fla. (www.fda.gov/cber/recalls/rtitis101405.htm)

Tutogen Medical, Inc., in Alachua, Fla. (www.fda.gov/cber/recalls/tutotis101205.htm)

The Blood and Tissue Center of Central Texas in Austin, Texas (www.fda.gov/cber/recalls/blotis101105.htm)

Lost Mountain Tissue Bank in Kennesaw, Ga. (www.fda.gov/cber/recalls/lmtbtis101005.htm)

AABB previously announced a recall by LifeCell Corp. in Branchburg, N.J. (www.fda.gov/cber/recalls/tislife093005.htm)  (Refer to AABB PulsePoints #718).

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