Device recall
Z-0818-04: ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT…
FDA device recall · Class III · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0818-04 |
|---|---|
| Recall event | 28728 |
| Product | ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038 |
| Product code | JJE |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 3, 2005 |
| 510(k) numbers | K980367, K983212 |
| FEI number | 1628664 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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