Recall notification - BD FACSTM Sample Prep Assistant II and III

Jul 8, 2019


BD has recently confirmed that BD FACSTM Sample Prep Assistant II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the System Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense. An inadequate sample dispense can create the potential for a falsely low CD4 count to occur. Current clinical guidelines use CD4, HIV viral load, and other disease sequelae for the overall evaluation of a patient’s disease burden. The risk associated with a falsely low CD4 count is initiation of prophylactic antibiotic therapy earlier than intended in the care of an HIV infected patient.

If you require further assistance, please contact BD Customer/Technical Support at 855-236-2772, Opt 2.

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