Device recall
Z-1399-2011: Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular…
FDA device recall · Class III · Abbott Molecular
Key facts
| Recall number (Z-number) | Z-1399-2011 |
|---|---|
| Recall event | 57431 |
| Product | Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantitation of Hepatitis B Virus (HBV) DNA in human plasma or serum from HBV-infected individuals. The… |
| Product code | MKT |
| Recalling firm | Abbott Molecular |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 19, 2012 |
| PMA numbers | P080026 |
| FEI number | 3005248192 |
At a glance
- None 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