Recall Z-1974-2023— QUIDEL CARDIOVASCULAR INC

Name: FDA recall Z-1974-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Class I · Ongoing

Class I FDA medical device recall by QUIDEL CARDIOVASCULAR INC, initiated 2023-05-25. It names one FDA 510(k) clearance: K030286. Product: Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.. Reason: 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..

Recalling firm: QUIDEL CARDIOVASCULAR INC
Classification: Class I
Status: Ongoing
Initiated: 2023-05-25
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K030286 — TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANELBiosite Incorporated·cleared 2003-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.