Danaher Corp.'s laboratory equipment unit Beckman Coulter Inc. recalled several blood analyzers due to the possibility of inaccurate results.
The U.S Food and Drug Administration has classified the recall as the most series type, because the blood tests could provide inaccurate blood platelet counts and place patients at risk of injury or death.
Included in the recall are Beckman Coulter's DxH 800, DxH 600 and DxH 900 blood analyzers. The devices are used to run diagnostic tests to count the different types of blood cells, oxygen level and volume of red blood cells in a sample.
The devices were occasionally giving out high platelet counts without any system messages, meaning that operators may not recognize the error, according to a May 23 press release posted on the FDA's website. Brea, Calif.-based Beckman Coulter initially informed customers about the problem in August 2018, but the recall has now been escalated after the company received complaints about inaccurate platelet counts, the FDA said.
The U.S. regulator said inaccurate platelet counts can lead to wrong decisions regarding platelet transfusion or surgeries, along with delayed or missed diagnoses of serious conditions.
Beckman Coulter has asked customers to update the software on their devices to get alerts for any inaccurate results. The FDA has yet to determine that the software update alone will adequately address the recall of the devices.
The FDA has asked laboratory operators to use backup analyzers or perform manual estimates before reporting platelet counts. The agency said more than 2,000 laboratories in the U.S. may be affected.