Alere Inc. has recalled 803,000 heart tests following an FDA Inspection of its San Diego plant raised concerns over quality control processes.
Alere Inc. has advised IMB that the heart tests were not supplied in Ireland and therefore the recall does not affect products sold here by the company.
Alere disclosed in regulatory documents on the 10th May 2012 that the FDA had concerns about the quality control release method for the companies triage products, which are rapid diagnostic tests systems used to diagnose heart conditions including heart failure.
