QUIDEL CARDIOVASCULAR INC
FDA Regulatory Profile
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 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200363 | Quidel Triage® TOX Drug Screen, 94600 | March 11, 2020 |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | June 19, 2019 |