NEW YORK (360Dx) – The US Food and Drug Administration said today that Beckman Coulter is recalling its DxH 800, DxH 600, and DxH 900 hematology analyzers "due to sporadic erroneously elevated platelet count results without flags or system messages, meaning there is no way for the laboratory operator of the test to recognize the error."
The FDA has identified this as a Class I recall, the most serious type of recall, in which use of the devices may cause serious injuries or death. However, the agency added that it is not aware of serious adverse events that have been directly linked to the hematology analyzers.
It noted that inaccurate platelet counts may cause serious adverse health consequences. These include an increased risk for life-threatening bleeding associated with withholding platelet transfusion or inappropriate decisions for surgeries or invasive procedures, as well as delayed or missed diagnosis of serious medical conditions, including thrombotic microangiopathy and heparin-induced thrombocytopenia.
The DxH 800, DxH 600, and DxH 900 analyzers run diagnostic tests that count the number of different types of red and white blood cells, platelets, oxygen levels, and volume of red blood cells in a blood sample in clinical laboratory settings. The tests may help providers diagnose diseases and conditions such as anemia, infections, clotting problems, blood cancers, and immune system disorders.
Parties affected by the recall include laboratory personnel who perform clinical testing using patient samples on the hematology analyzers, healthcare providers who interpret the clinical test results, and patients being tested with the analyzers, the FDA said.
The agency added that Beckman Coulter on Monday notified customers of an updated urgent medical device recall letter, which replaces an initial notification letter dated July 30, 2018. In the updated letter, customers, among other actions, are advised to share the letter with laboratory staff and retain it as part of their laboratory quality system documentation. Laboratories are also advised to run samples on an instrument not subject to the recall to confirm the platelet results, and if an alternative instrument is not available, use specified quality control measures to aid in identification of discrepant platelet results, the FDA said.