FDA is alerting hospitals, laboratories, and healthcare providers about a Class I recall of 3,428 Beckman Coulter DxH 600, DxH 800, and DxH 900 hematology analyzers. The agency’s alert is an update to an urgent medical device correction letter first issued by Beckman Coulter in 2018, after the company received reports of inaccurate blood platelet counts.

Beckman Coulter DxH 900  analyzer.

Beckman Coulter DxH 900 analyzer.

The DxH 600, DxH 800, and DxH 900 are hematology analyzers used in clinical laboratory settings. The instruments perform diagnostic tests that count the number of red and white blood cells in a blood sample, and provide measurements of a patient’s hematocrit, hemoglobin, and platelet levels. Such tests help providers diagnose diseases and conditions such as anemia (low red blood cell or hemoglobin count), blood cancers, blood clotting problems, immune system disorders, and infections.

“Inaccurate platelet counts may create serious health risks for patients,” notes Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “An inaccurate result may lead a provider to conclude a patient is suitable for surgery when they may not be, to withhold platelet transfusion in patients who may need it, or to delay or miss the diagnosis of serious blood disorders. Because this may cause serious injury, or even death, to a patient, we are urging healthcare professionals to be aware of the potential for inaccurate diagnostic results with these analyzers and to take appropriate actions, including the use of alternative diagnostic testing or confirming analyzer results with manual scanning or estimate of platelets. We are working with the manufacturer to correct the problem with the devices as quickly as possible and will continue to communicate as more information becomes available.”

Beckman Coulter first notified its customers about the recall at the end of July 2018, after receiving notice of sporadic, erroneously elevated platelet count results without alerts or system error messages—meaning that laboratory operators of the instruments would have no way to recognize the error. Inaccurate platelet counts may result in such serious adverse health consequences as increased risk of life-threatening bleeding associated with withholding platelet transfusions; inappropriate decisions about surgeries or invasive procedures; and delayed or missed diagnosis of serious medical conditions, including thrombotic microangiopathy and heparin-induced thrombocytopenia.

After assessing company information about the results of its initial recall, FDA asked Beckman Coulter to send a second medical device correction letter to its customers, and to send an additional letter to physicians likely to have patients affected by inaccurate hematology test results. Beckman Coulter sent the updated letters on May 20, emphasizing that both pathologists and clinicians should be aware of the recall and understand the steps that should be taken to ensure that accurate and appropriate patient assessments are conducted. The company’s updated medical device recall letters advised recipients to:

  • Share the letter with laboratory staff and retain the notification as part of the laboratory’s quality system documentation.
  • Notify any other laboratories that may have had instruments transferred there.
  • Confirm receipt of the letter within 10 days.

FDA added its voice to the communications in order to ensure that all hospitals, laboratories, healthcare professionals, and patients have appropriate information about the seriousness of the recall and the actions that should be taken. Before reporting platelet counts out of the laboratory, the agency recommends that laboratory personnel confirm the platelet results by using backup analyzers, if available, or by performing manual platelet estimate/screening (see the companion article, “Running Samples”). Laboratories that continue to use the recalled analyzers for complete blood counts (CBC) should report unflagged, erroneously high platelet count results to Beckman Coulter and FDA.

The agency also encourages laboratories to contact any ordering physicians who may be affected, to discuss whether retesting of recently tested patients is appropriate. Healthcare providers who are interpreting such test results for their patients should discuss any concerns about the testing process with the clinical laboratory processing their samples, and should consider all available clinical information when formulating their treatment recommendations.

FDA is aware of more than 2,000 US laboratories that may be affected by the recalls, but it is unable to determine how many patient samples may have been affected. The agency has not received any reports of serious adverse events linked directly to the recalled analyzers. The following individuals may be affected by the recall:

  • Laboratory personnel who perform clinical testing using patient samples on the hematology analyzers.
  • Healthcare providers who interpret these clinical test results.
  • Patients being tested with the DxH 600, DxH 800, or DxH 900 hematology analyzers.

FDA encourages healthcare professionals and laboratory personnel to report adverse events or quality problems experienced with the use of the recalled products to the agency’s MedWatch adverse event reporting program.

FDA is continuing to investigate the issue of erroneous platelet counts, and is working with Beckman Coulter to implement appropriate patient safety mitigations. The company has indicated that a software update to the recalled instruments may serve to alert laboratory personnel to any inaccurate results. However, FDA has not evaluated the updated software, and is working with the company to determine whether a software update alone can adequately address the issues that led to recall of the devices.

For further information, visit Beckman Coulter and FDA.

Featured image: Photo ©Aquir Dreamstime (ID 122108415).