Device recall
Z-1934-2016: Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1934-2016 |
|---|---|
| Recall event | 73921 |
| Product | Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers. |
| Product code | CDT |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2016 |
| 510(k) numbers | K063804 |
| FEI number | 2050012 |
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