Brand
QUIDEL CARDIOVASCULAR INC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for QUIDEL CARDIOVASCULAR INC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-07-12FDA-DeviceClass IQuidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.
Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis.
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