Device recall
Z-1160-2008: Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a…
FDA device recall · Class II · Beckman Coulter Inc
Key facts
| Recall number (Z-number) | Z-1160-2008 |
|---|---|
| Recall event | 45955 |
| Product | Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318. |
| Product code | CFP |
| Recalling firm | Beckman Coulter Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2012 |
| 510(k) numbers | K953084 |
| FEI number | 2050012 |
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