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# Don’t Use Quidel Triage Cardiac Panel: FDA
- URL: https://www.fdaweb.com/dont-use-quidel-triage-cardiac-panel-fda/
- Published: 2023-07-19T12:00:00.000Z
- Updated: 2026-09-14T18:45:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154904

FDA is recommending that healthcare providers, laboratory personnel, and facilities stop using the Quidel Triage Cardiac Panel manufactured by Quidel Cardiovascular. A 7/19 agency [notice](https://www.fda.gov/medical-devices/letters-health-care-providers/use-alternative-testing-method-quidel-cardiovascular-inc-quidel-triage-cardiac-panel-letter-health?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the company issued an urgent product correction notification on 5/25 recalling specific lots of the device after hearing that tests provide inaccurate, lower-than-expected troponin levels in samples. The company issued an updated notice on 7/12 with additional recommendations to affected customers who did not confirm they have alternative testing methods available.

FDA says falsely low or false negative troponin test results may lead to failure to timely diagnose myocardial infarction and failure to begin appropriate intervention to prevent damage or injury to the heart muscle.

FDA recommends that healthcare providers, laboratory personnel, and facilities using the Quidel panel:

- immediately stop using the product and use an alternative method; and
- if no alternative method is available, consider sending patients to another local testing site in which an alternative method is available.

The document lists steps Quidel recommends if an alternative method or testing site is not available.

FDA says this is a Class 1 recall and says it is working with the company to further evaluate the issue and identify potential contributing factors.