Device recall
Z-0365-2014: Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct…
FDA device recall · Class II · Siemens Healthcare Diagnostics
Key facts
| Recall number (Z-number) | Z-0365-2014 |
|---|---|
| Recall event | 66396 |
| Product | Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human… |
| Product code | CIG |
| Recalling firm | Siemens Healthcare Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2018 |
| 510(k) numbers | K050374 |
| FEI number | 2432235 |
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