Device recall
Z-0557-2014: VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0557-2014 |
|---|---|
| Recall event | 66900 |
| Product | VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs |
| Product code | LOM |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 2018 |
| PMA numbers | P000014, P000014S025 |
| FEI number | 1000136573 |
At a glance
- None 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