Beckman Coulter—COULTER LH and HmX Analyzers: May Not Flag or Detect Blasts
July 5, 2017 | Risk Management News
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In a June 20, 2017, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Beckman Coulter states that the above analyzers may not flag or detect blasts in some blood samples because of limitations in the available technology and the properties of blasts in certain samples. Beckman Coulter also states that if these limitations are not clearly understood or are misinterpreted, the recognition, diagnosis, and treatment of conditions associated with blasts in the peripheral blood may be delayed. The manufacturer has not confirmed the...