Device recall
Z-1218-03: AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo…
FDA device recall · Class II · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-1218-03 |
|---|---|
| Recall event | 27069 |
| Product | AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA |
| Product code | LPS |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 20, 2004 |
| 510(k) numbers | K992858 |
| FEI number | 1415939 |
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