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QUIDEL CARDIOVASCULAR Recalls
2 recalls on record · April 1, 2020 to July 12, 2023 · Medical Devices
Recalls by year
20
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 12, 2023Medical DevicesFDA
QUIDEL CARDIOVASCULAR INC recalls Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP,
Hazard: 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.
April 1, 2020Medical DevicesFDA
QUIDEL CARDIOVASCULAR INC recalls Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel
Hazard: Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.