Device recall
Z-1790-2010: Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each…
FDA device recall · Class II · Biosite Inc
Key facts
| Recall number (Z-number) | Z-1790-2010 |
|---|---|
| Recall event | 54276 |
| Product | Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. Intended use: Materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to verify… |
| Product code | jjy |
| Recalling firm | Biosite Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2011 |
| 510(k) numbers | K072892 |
| FEI number | 1000125596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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