Device recall
Z-0076-2007: Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540…
FDA device recall · Class II · Stanbio Laboratory, Inc
Key facts
| Recall number (Z-number) | Z-0076-2007 |
|---|---|
| Recall event | 36436 |
| Product | Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. |
| Product code | LBR |
| Recalling firm | Stanbio Laboratory, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2007 |
| 510(k) numbers | K992002 |
| FEI number | 1616487 |
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