Device recall
Z-0629-2011: ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-0629-2011 |
|---|---|
| Recall event | 56757 |
| Product | ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list… |
| Product code | DLJ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2011 |
| 510(k) numbers | K072036 |
| FEI number | 1415939 |
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