The Food and Drug Administration (FDA), on July 17, identified the recall by Quidel Cardiovascular Inc of its Quidel Triage Cardiac Panels as Class I, the most serious.
The recall was initiated because of reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely low or negative troponin level may cause a delayed or missed diagnosis of myocardial infarction.
The company reports 41 complaints, no injuries, and no deaths related to this issue.
Distribution dates: Beginning November 1, 2022.Read More >>