During a routine release and investigational testing of NaturaLyte ® Liquid Sodium Bicarbonate Concentrate, one (1) bottle out of 2,351 (0.04%) tested positive for Dietzia sp ( colony forming unit (CFU) count of 2,790 CFU per mL). This result is out of internal specification for product release (the current CAN:CSA/ISO/AAMI standard of the final diluted dialysate is a colony count of less than 100 CFU per mL). The affected lot was not distributed in Canada, however the possibility that other lots manufactured in 2015 may also be affected cannot be excluded.
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