QUIDEL CARDIOVASCULAR INC
QUIDEL CARDIOVASCULAR INC appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1974-2023, Class I) was initiated on May 25, 2023. Its most recent 510(k) clearance was granted on March 11, 2020.
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1974-2023 | Class I | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 970 | May 25, 2023 |
| Z-1552-2020 | Class II | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vial | April 9, 2019 |