Device recall
Z-2613-2017: ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-2613-2017 |
|---|---|
| Recall event | 77070 |
| Product | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen… |
| Product code | CDZ |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2019 |
| 510(k) numbers | K060818 |
| FEI number | 1415939 |
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