Urgent Instruction Correction: Biotest Tango Automated Blood Bank Analyzer, Biotest AG-Dreieich

Biotest Tango Automated Blood Bank Analyzer

DATE NOTIFICATION INITIATED:

February 26, 2009

PRODUCT / LOT NUMBER:

Antibody Screen Wash with De-ionized Water, Software Version 3.1

MANUFACTURER:

Biotest AG-Dreieich
Dreieich, Germany

REASON:

Biotest discovered that in rare instances, antibody screen testing may be washed using de-ionized water (System Liquid) instead of the intended Phosphate Buffered Saline (PBS, Wash Solution). This event will not cause an erroneous patient or control result, however an invalid result will occur due to the hemolysis of the Reagent Red Blood Cells. Customers were provided with instructions to avoid this situation in the notification.

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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.