This is a companion article to the news story, “Beckman Coulter Updates Hematology Analyzer Recall.”

In its updated recall letter for the DxH 600, DxH 800, and DxH 900 hematology analyzers, Beckman Coulter advises customers to confirm their platelet test results by running samples on an instrument not subject to the recall. Additional comments and recommendations provided in the company’s letter include the following.

• If an alternative instrument is not available, use the following quality control measures to aid in identification of discrepant platelet results:
  • Perform manual scanning or estimate of platelets on a peripheral smear and compare with instrument results. Note that this method will identify samples with marked to moderate thrombocytopenia but may not identify smaller discrepancies.
  • Repeat testing of samples in a workflow configuration may facilitate the identification of discrepancies.
  • If an erroneous result is detected, review results from adjacent samples, such as those tested on the instrument both before and after the erroneous result.
  • Additional instrument or laboratory information system features—including reference ranges, exponentially-weighted moving averages, and delta checks—may be informative.
  • Follow the laboratory’s standard operating procedure to confirm unexpected results.
• Ongoing investigation indicates that sweep flow disruption may occur following the ‘clear RBC apertures’ procedure. This potential root cause is currently under further investigation. Customers should discontinue using this procedure. A lab that suspects its instrument has a clogged aperture that will not clear should discontinue use of the analyzer and contact the Beckman Coulter customer support center to request service.
• Labs should communicate to ordering physicians the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features. Physicians should be vigilant when reviewing platelet count results, particularly in patients at risk for thrombocytopenia—such as those associated with alcohol abuse, anemia, autoimmune diseases, hypersplenism, infection, leukemia, pregnancy, or thrombotic microangiopathy—or patients on chemotherapy, receiving heparin treatment, or taking certain medications, including anticonvulsants, quinine, and sulfonamide antibiotics.
• Labs should consult with their medical directors to determine whether a retrospective review of results is warranted.
• Labs should report any unflagged erroneously elevated platelet counts they experience to Beckman Coulter and FDA.

Beckman Coulter continues to investigate the unflagged elevated platelets issue, and is assessing the ‘clear RBC apertures’ procedure as well as other potential root or contributing causes. The company’s software algorithm improvement is currently being evaluated. This evaluation includes customers whose systems already have the updated software versions with the algorithm improvement.

 This is a companion article to the feature, “Beckman Coulter Updates Hematology Analyzer Recall.”

In its updated recall letter for the DxH 600, DxH 800, and DxH 900 hematology analyzers, Beckman Coulter advises customers to confirm their platelet test results by running samples on an instrument not subject to the recall. Additional comments and recommendations provided in the company’s letter include the following.

• If an alternative instrument is not available, use the following quality control measures to aid in identification of discrepant platelet results:
• Perform manual scanning or estimate of platelets on a peripheral smear and compare with instrument results. Note that this method will identify samples with marked to moderate thrombocytopenia but may not identify smaller discrepancies.
• Repeat testing of samples in a workflow configuration may facilitate the identification of discrepancies. If an erroneous result is detected, review results from adjacent samples, such as those tested on the instrument both before and after the erroneous result.
• Additional instrument or laboratory information system features—including reference ranges, exponentially-weighted moving averages, and delta checks—may be informative.
• Follow the laboratory’s standard operating procedure to confirm unexpected results.
• Ongoing investigation indicates that sweep flow disruption may occur following the ‘clear RBC apertures’ procedure. This potential root cause is currently under further investigation. Customers should discontinue using this procedure. A lab that suspects its instrument has a clogged aperture that will not clear should discontinue use of the analyzer and contact the Beckman Coulter customer support center to request service.
• Labs should communicate to ordering physicians the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features. Physicians should be vigilant when reviewing platelet count results, particularly in patients at risk for thrombocytopenia—such as those associated with alcohol abuse, anemia, autoimmune diseases, hypersplenism, infection, leukemia, pregnancy, or thrombotic microangiopathy—or patients on chemotherapy, receiving heparin treatment, or taking certain medications, including anticonvulsants, quinine, and sulfonamide antibiotics.
• Labs should consult with their medical directors to determine whether a retrospective review of results is warranted.
• Labs should report any unflagged erroneously elevated platelet counts they experience to Beckman Coulter and FDA.

Beckman Coulter continues to investigate the unflagged elevated platelets issue, and is assessing the ‘clear RBC apertures’ procedure as well as other potential root or contributing causes. The company’s software algorithm improvement is currently being evaluated. This evaluation includes customers whose systems already have the updated software versions with the algorithm improvement.