Device recall
Z-1391-2009: Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched…
FDA device recall · Class I · Biosite Inc
Key facts
| Recall number (Z-number) | Z-1391-2009 |
|---|---|
| Recall event | 51925 |
| Product | Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, creatine kinase MB fraction (CK-MB), and troponin I in EDTA whole blood and… |
| Product code | MMI |
| Recalling firm | Biosite Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 6, 2010 |
| 510(k) numbers | K030286 |
| FEI number | 1000125596 |
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