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DATE RECALL INITIATED: December 23, 2003 LOT NUMBER / EXPIRATION DATE: 8S243     1/13/2004 MANUFACTURER: Ortho Clinical Diagnostics, Inc. Raritan, New Jersey REASON: Ortho Clinical Diagnostics (OCD) received complaints of variations (both high and low) in the Cell II (R2R2) concentration contained within Reagent Red Blood Cells, 0.8%, Selectogen, Lot 8S243. OCD has confirmed that Cell II was manufactured outside of product specifications. 0.8% Selectogen Cells are used with the Ortho BioVue System and the ID-Micro Typing System Gel Test Methods for detection of unexpected blood group antibodies. As addressed in the MTS Anti-IgG package insert (revision date 12-19-2000), increased or decreased cell concentration may cause inaccurate results. Consignees were asked to discontinue using and discard remaining inventory of the Reagent Red Blood Cells. 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.

Updated March 1, 2004

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