Device recall
Z-3031-2011: ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-3031-2011 |
|---|---|
| Recall event | 59335 |
| Product | ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of C-Peptide in human serum, plasma and urine on the ARCHITECT i System; Produced by Biokit S.A., 08186 Barcelona, Spain for Abbott Diagnostics Division, Distributed by Abbott… |
| Product code | JKD |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2012 |
| FEI number | 1415939 |
At a glance
- None 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