FDA Class I Recall: Stop using the Quidel Triage Cardiac Panel

Quidel Cardiovascular Inc. is recalling the Quidel Triage Cardiac Panel after reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely low or false negative troponin test result may cause a delayed or missed MI diagnosis, particularly NSTEMI, as well as failure to begin appropriate clinical intervention. The FDA urges HCPs, lab personnel, and facilities to immediately stop using this product and to use an alternate method. If no alternate method is available, consider sending patients to another testing site in which an alternate method is available.