Device recall
Z-1046-2009: AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1046-2009 |
|---|---|
| Recall event | 50816 |
| Product | AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator… |
| Product code | LOM |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2010 |
| PMA numbers | P050049, P050049S002 |
| FEI number | 1415939 |
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