Device recall
Z-0407-2017: Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-0407-2017 |
|---|---|
| Recall event | 75526 |
| Product | Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. |
| Product code | JIS |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2018 |
| 510(k) numbers | K994278 |
| 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