Dive Brief:

• Beckman Coulter is recalling hematology analyzers due to a platelet counting fault that FDA said could lead to serious injuries and death.

• The company alerted customers to the problem but FDA, after receiving additional information, asked the company to send a second letter and contact physicians likely to have patients affected by the inaccurate results.

• FDA knows of more than 2,000 U.S. laboratories that may be affected by the faulty platelet counting but hasn't yet received any serious adverse events linked to the DxH 800, DxH 600 and DxH 900 hematology analyzers.

Dive Insight:

Large medical centers, small community hospitals and other locations use the devices as part of routine check-ups, pre-surgical assessments and to identify patients who need platelet transfusions. In August 2018, Beckman Coulter told customers it had evidence the devices were providing falsely elevated platelet results without issuing an error alert. Some labs failed to reply to the notice.

In light of information shared by Beckman Coulter last month, FDA wants to make sure all users are aware of the problem. Beckman Coulter issued letters to physicians and FDA posted a press release. 

"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," Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at FDA, said in a statement. FDA classed the recall as a Class I event.

FDA is urging healthcare professionals to be aware of the potential for inaccurate results and to take steps to mitigate any adverse consequences by using backup analyzers or manual platelet screening estimates. Beckman Coulter recommended the repeat testing of samples, too.

Work is underway to fix the problem. Beckman Coulter's investigation suggests the problem may occur following the "Clear RBC Apertures" procedure but it hasn't yet determined the root cause.

While that work is ongoing, Beckman Coulter is advising users not to perform the procedure and is rolling out an algorithm designed to detect and flag false results as they arise. Beckman Coulter made the patch available in October but FDA hasn't yet evaluated whether the software, meaning it cannot whether the software is sufficient to address the issues identified in the recall.

The recall and remedial actions are focused on the platelet analyzing function of the devices. There is no evidence that the devices' ability to measure other factors, such as white blood cells, is flawed.