Device recall
Z-0435-05: B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0435-05 |
|---|---|
| Recall event | 30764 |
| Product | B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas |
| Product code | LID |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2005 |
| 510(k) numbers | K984108 |
| FEI number | 1628664 |
At a glance
- 1–9 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