Vaccines, Blood & Biologics

Recall of AbSorber XM-ONE Transplantation Cross Match, ABX100-03

DATE RECALL INITIATED: July 16, 2014

PRODUCT:

AbSorber XM-ONE Transplantation Cross Match, ABX100-03; Lot Number 14E03002

  • Containing BD Vacutainer CPT (Lot Number 4063455)

MANUFACTURER:

Olerup SSP AB
Stockholm, Sweden

REASON:

BD Diagnostics has identified through customer feedback that the Cell Preparation Tube (CPT) lot number 4063455 has the potential for poor separation, resulting in a reduced number of recovered mononuclear cells. Low or no yield of cells might lead to an incomplete crossmatch result and no data available for medical decision and thereby potential delay of treatment. Consignees are asked to put affected XM-ONE, Lot number 14E03002 in quarantine and review analysis data from XM-ONE assays made with this lot.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Page Last Updated: 08/05/2014
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