Device recall
Z-1974-2023: Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB…
FDA device recall · Class I · QUIDEL CARDIOVASCULAR INC
Key facts
| Recall number (Z-number) | Z-1974-2023 |
|---|---|
| Recall event | 92447 |
| Product | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045. |
| Product code | MMI |
| Recalling firm | QUIDEL CARDIOVASCULAR INC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K030286 |
| FEI number | 3013982035 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database