Device recall
Z-1596-2010: ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA)…
FDA device recall · Class II · Abbott Diagnostics International, Ltd.
Key facts
| Recall number (Z-number) | Z-1596-2010 |
|---|---|
| Recall event | 55165 |
| Product | ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. |
| Product code | LOL |
| Recalling firm | Abbott Diagnostics International, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2011 |
| 510(k) numbers | K063329 |
| FEI number | 2623532 |
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