Beckman Coulter Life Sciences has recalled several of its hematology analyzers due to the risk of inaccurate results, according to a U.S. Food and Drug Administration (FDA) notification from May 23. Some 2,000 clinical labs in the U.S. may be affected by the recall.
The recalled products include the company's DxH 800, DxH 600, and DxH 900 analyzers, the FDA said. The agency noted the action was classified as a class I recall, the most serious type of recall, in which use of the devices could cause serious injury or death. The FDA pointed out, however, that it was not aware of any serious adverse events that had resulted from use of the analyzers.
The analyzers perform diagnostic tests that count the number of different types of red and white blood cells, platelets, hemoglobin (oxygen levels), and hematocrit (volume of red blood cells in blood) levels in blood samples in clinical lab settings. They are designed to help clinicians diagnose conditions such as anemia, infections, clotting problems, blood cancers, and disorders of the immune system.
The company is performing the recall because the analyzers can sporadically record erroneously elevated platelet counts without flags or system messages; this means that lab operators have no way to recognize that errors are occurring, according to the FDA.
Beckman Coulter originally notified customers of the issue in April 2018. After the company submitted additional information to the FDA in April 2019, the agency asked the company to send a second urgent medical device correction letter to customers, which the company did on May 20.
The FDA said it was announcing the recall to make sure that hospitals, clinical labs, healthcare professionals, and patients have the appropriate information about the seriousness of the recall and recommended actions to take.
"The company has indicated to customers that a software update to the device may serve to alert laboratory personnel to any inaccurate results," the FDA noted. "However, the FDA has not evaluated the software and is working with the company to determine if the software update alone can adequately address the recall of this device."
The FDA is advising that lab personnel use backup analyzers to confirm platelet results or perform manual platelet estimate/screening. The agency also advises users to follow guidance in Beckman Coulter's May 20 letter before reporting results out of the lab.
The FDA believes that over 2,000 clinical labs in the U.S. may be affected by the recall, ranging from large medical centers to small community hospitals. The agency said it has not been able to determine how many patient samples are affected, and it reiterated that it had not received reports of any serious adverse events linked to the analyzers covered in the recall.