Device recall
Z-0688-2019: VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro…
FDA device recall · Class II · ORTHO-CLINICAL DIAGNOSTICS
Key facts
| Recall number (Z-number) | Z-0688-2019 |
|---|---|
| Recall event | 81682 |
| Product | VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the… |
| Product code | LOM |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P090028 |
| FEI number | 3007111389 |
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