Device recall
Z-1902-2012: MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay…
FDA device recall · Class II · Sekisui Diagnostics Llc
Key facts
| Recall number (Z-number) | Z-1902-2012 |
|---|---|
| Recall event | 62017 |
| Product | MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. |
| Product code | LDP |
| Recalling firm | Sekisui Diagnostics Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 14, 2012 |
| 510(k) numbers | K042330 |
| FEI number | 3008776041 |
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